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Article ; Online: Bariatrics and endoscopic therapies for the treatment of metabolic disease: Past, present, and future.

Mingrone, Geltrude / Rajagopalan, Harith

2024 Volume 211, Page(s) 111651

Abstract: The burden of chronic metabolic diseases such as obesity, type 2 diabetes mellitus (T2DM), and metabolic dysfunction-associated steatotic liver disease (MASLD) and the urgency of the epidemiological situation necessitate the development of therapies that ...

Abstract	The burden of chronic metabolic diseases such as obesity, type 2 diabetes mellitus (T2DM), and metabolic dysfunction-associated steatotic liver disease (MASLD) and the urgency of the epidemiological situation necessitate the development of therapies that enhance metabolic health and alter the trajectory of metabolic disease in society. Certain bariatric-metabolic surgeries have proven to be effective approaches for treating metabolic dysfunction, showing remission or significant improvements in obesity, T2DM, and MASLD-related outcomes, suggesting that these interventions might be able to "reset" a pathologically calibrated metabolic setpoint. However, considering the challenges and invasiveness of surgery, endoscopic bariatric metabolic therapies (EBMTs) have emerged with a primary focus to reconstruct or mimic anatomical and/or functional changes observed with bariatric surgery in a more broadly accessible manner. These innovative approaches offer a potentially promising solution to address significant unmet medical need in the large segment of society, which remains at risk for the consequences of metabolic diseases. In this review, we discuss therapeutic options within the EBMT space in the context of the metabolic setpoint intellectual model and provide a brief overview of current knowledge surrounding their mechanisms of action and impact on metabolic health. Finally, we explore future perspectives and directions in this exciting field.
Language	English
Publishing date	2024-04-03
Publishing country	Ireland
Document type	Journal Article
ZDB-ID	632523-3
ISSN	1872-8227 ; 0168-8227
ISSN (online)	1872-8227
ISSN	0168-8227
DOI	10.1016/j.diabres.2024.111651
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Article ; Conference proceedings: A prospective post-market clinical follow-up registry to evaluate real-world effectiveness of duodenal mucosal resurfacing in patients with type 2 diabetes

Martin, Stephan / Veiser, Thomas / Cozzi, Emily / Rajagopalan, Harith / White, Kelly / Beyna, Torsten

Diabetologie und Stoffwechsel

(Diabetes Kongress 2024 – 58. Jahrestagung der DDG)

2024 Volume 19, Issue S 01

Event/congress	Diabetes. Umwelt. Leben. Perspektiven aus allen Blickwinkeln, CityCube Berlin, 2024-05-08
Series title	Diabetes Kongress 2024 – 58. Jahrestagung der DDG
Language	German
Publishing date	2024-04-01
Publisher	Georg Thieme Verlag KG
Publishing place	Stuttgart ; New York
Document type	Article ; Conference proceedings
ZDB-ID	2222993-0
ISSN	1861-9010 ; 1861-9002
ISSN (online)	1861-9010
ISSN	1861-9002
DOI	10.1055/s-0044-1785274
Database	Thieme publisher's database

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Article ; Online: Insulin sensitivity and beta cell function after Duodenal Mucosal Resurfacing (DMR): An Open-Label, Mechanistic, Pilot Study.

Busch, Celine B E / Meiring, Suzanne / van Baar, Annieke C G / Gastaldelli, Amalia / DeFronzo, Ralph / Mingrone, Geltrude / Hagen, Moira / White, Kelly / Rajagopalan, Harith / Nieuwdorp, Max / Bergman, Jacques J G H M

Gastrointestinal endoscopy

2024

Abstract: Background and aims: The duodenum has been shown to play a key role in glucose homeostasis. Duodenal mucosal resurfacing (DMR) is an endoscopic procedure for patients with type 2 diabetes (T2D) in which the duodenal mucosa is hydrothermally ablated. DMR ...

Abstract	Background and aims: The duodenum has been shown to play a key role in glucose homeostasis. Duodenal mucosal resurfacing (DMR) is an endoscopic procedure for patients with type 2 diabetes (T2D) in which the duodenal mucosa is hydrothermally ablated. DMR improves glycemic control, but the underlying mechanisms remain unclear. Here, we report changes in glucoregulatory hormones and indices of insulin sensitivity and beta cell function after DMR. Methods: We included 28 patients on non-insulin glucose lowering medications who underwent open-label DMR and a mixed meal test (MMT) in Revita-1 or Revita-2. Inclusion criteria were hemoglobin A1c (HbA1c) 7.6-10.4% and BMI 24-40kg/m Results: Fasting insulin, glucagon, and C-peptide decreased significantly. Insulin sensitivity (HOMA-IR, MI, and HIR) and beta cell function (DI and ISR) all improved significantly. Decline in postprandial glucose, mainly driven by a decrease in fasting levels, was observed, as well as a decline in postprandial glucagon whereas GLP-1 and GIP did not change. Conclusions: Insulin sensitivity and insulin secretion improved 3 months after DMR. It is unlikely that incretin changes are responsible for improved glucose control after DMR. These data add to the growing evidence validating the duodenum as a therapeutic target for patients with T2D.
Language	English
Publishing date	2024-01-25
Publishing country	United States
Document type	Journal Article
ZDB-ID	391583-9
ISSN	1097-6779 ; 0016-5107
ISSN (online)	1097-6779
ISSN	0016-5107
DOI	10.1016/j.gie.2024.01.031
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Article ; Online: A Gut-Centric Model of Metabolic Homeostasis.

Rajagopalan, Harith / Lopez-Talavera, Juan Carlos / Klonoff, David C / Cherrington, Alan D

Journal of diabetes science and technology

2021 Volume 16, Issue 6, Page(s) 1567–1574

Abstract: Modern changes in diet and lifestyle have led to an explosion of insulin resistance and metabolic diseases around the globe which, if left unchecked, will become a principal driver of morbidity and mortality in the 21st century. The nature of the ... ...

Abstract	Modern changes in diet and lifestyle have led to an explosion of insulin resistance and metabolic diseases around the globe which, if left unchecked, will become a principal driver of morbidity and mortality in the 21st century. The nature of the metabolic homeostatic shift within the body has therefore become a topic of considerable interest. While the gut has long been recognized as an acute nutrient sensor with signaling mechanisms to the other metabolic organs of the body, its role in regulating the body's metabolic status over longer periods of time has been underappreciated. Recent insights from bariatric surgery and intestinal nutrient stimulation experiments provide a window into the adaptive role of the intestinal mucosa in a foregut/hindgut metabolic balance model that helps to define metabolic parameters within the body-informing the metabolic regulation of insulin resistance versus sensitivity, hunger versus satiety, energy utilization versus energy storage, and protection from hypoglycemia versus protection from hyperglycemia. This intestinal metabolic balance model provides an intellectual framework with which to understand the distinct roles of proximal and distal intestinal segments in metabolic regulation. The model may also aid in the development of novel disease-modifying therapies that can correct the dysregulated metabolic signals from the intestine and stem the tide of metabolic diseases in society.
MeSH term(s)	Humans ; Insulin Resistance ; Bariatric Surgery ; Homeostasis ; Intestinal Mucosa/surgery ; Energy Metabolism ; Diabetes Mellitus, Type 2
Language	English
Publishing date	2021-10-26
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	1932-2968
ISSN (online)	1932-2968
DOI	10.1177/19322968211044523
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Article ; Online: Hydrothermal Duodenal Mucosal Resurfacing: Role in the Treatment of Metabolic Disease.

Cherrington, Alan D / Rajagopalan, Harith / Maggs, David / Devière, Jacques

Gastrointestinal endoscopy clinics of North America

2017 Volume 27, Issue 2, Page(s) 299–311

Abstract: The duodenum has become recognized as a metabolic signaling center that is involved in regulating insulin action and, therefore, insulin resistance states such as type 2 diabetes. Bariatric surgery and other manipulations of the upper intestine, in ... ...

Abstract	The duodenum has become recognized as a metabolic signaling center that is involved in regulating insulin action and, therefore, insulin resistance states such as type 2 diabetes. Bariatric surgery and other manipulations of the upper intestine, in particular the duodenum, have shown that limiting nutrient exposure or contact in this key region exerts powerful metabolic effects. Early human clinical trial data suggest that endoscopic hydrothermal duodenal mucosal resurfacing is well tolerated in human subjects and has an acceptable safety profile. This article describes the rationale for this endoscopic approach and its early human use, including safety, tolerability, and early efficacy.
MeSH term(s)	Bariatric Surgery/methods ; Catheter Ablation/methods ; Diabetes Mellitus, Type 2/surgery ; Duodenoscopy/methods ; Duodenum/surgery ; Fatty Liver/surgery ; Humans ; Insulin Resistance ; Intestinal Mucosa/surgery ; Metabolic Syndrome/surgery
Keywords	covid19
Language	English
Publishing date	2017-04
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1313994-0
ISSN	1558-1950 ; 1052-5157
ISSN (online)	1558-1950
ISSN	1052-5157
DOI	10.1016/j.giec.2016.12.002
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Article ; Online: Chronic peptide-based GIP receptor inhibition exhibits modest glucose metabolic changes in mice when administered either alone or combined with GLP-1 agonism.

West, Jason A / Tsakmaki, Anastasia / Ghosh, Soumitra S / Parkes, David G / Grønlund, Rikke V / Pedersen, Philip J / Maggs, David / Rajagopalan, Harith / Bewick, Gavin A

PloS one

2021 Volume 16, Issue 3, Page(s) e0249239

Abstract: Combinatorial gut hormone therapy is one of the more promising strategies for identifying improved treatments for metabolic disease. Many approaches combine the established benefits of glucagon-like peptide-1 (GLP-1) agonism with one or more additional ... ...

Abstract	Combinatorial gut hormone therapy is one of the more promising strategies for identifying improved treatments for metabolic disease. Many approaches combine the established benefits of glucagon-like peptide-1 (GLP-1) agonism with one or more additional molecules with the aim of improving metabolic outcomes. Recent attention has been drawn to the glucose-dependent insulinotropic polypeptide (GIP) system due to compelling pre-clinical evidence describing the metabolic benefits of antagonising the GIP receptor (GIPR). We rationalised that benefit might be accrued from combining GIPR antagonism with GLP-1 agonism. Two GIPR peptide antagonists, GIPA-1 (mouse GIP(3-30)NH2) and GIPA-2 (NαAc-K10[γEγE-C16]-Arg18-hGIP(5-42)), were pharmacologically characterised and both exhibited potent antagonist properties. Acute in vivo administration of GIPA-1 during an oral glucose tolerance test (OGTT) had negligible effects on glucose tolerance and insulin in lean mice. In contrast, GIPA-2 impaired glucose tolerance and attenuated circulating insulin levels. A mouse model of diet-induced obesity (DIO) was used to investigate the potential metabolic benefits of chronic dosing of each antagonist, alone or in combination with liraglutide. Chronic administration studies showed expected effects of liraglutide, lowering food intake, body weight, fasting blood glucose and plasma insulin concentrations while improving glucose sensitivity, whereas delivery of either GIPR antagonist alone had negligible effects on these parameters. Interestingly, chronic dual therapy augmented insulin sensitizing effects and lowered plasma triglycerides and free-fatty acids, with more notable effects observed with GIPA-1 compared to GIPA-2. Thus, the co-administration of both a GIPR antagonist with a GLP1 agonist uncovers interesting beneficial effects on measures of insulin sensitivity, circulating lipids and certain adipose stores that seem influenced by the degree or nature of GIP receptor antagonism.
MeSH term(s)	Amino Acid Sequence ; Animals ; Blood Glucose/analysis ; Body Weight/drug effects ; Diet, High-Fat/veterinary ; Fatty Acids/blood ; Gastric Inhibitory Polypeptide/chemistry ; Gastric Inhibitory Polypeptide/pharmacology ; Glucagon-Like Peptide 1/agonists ; Glucagon-Like Peptide 1/metabolism ; Glucagon-Like Peptide-1 Receptor/antagonists & inhibitors ; Glucagon-Like Peptide-1 Receptor/metabolism ; Glucose/metabolism ; Glucose Tolerance Test ; Insulin Secretion ; Liraglutide/pharmacology ; Male ; Mice ; Mice, Inbred C57BL ; ROC Curve ; Triglycerides/blood
Chemical Substances	Blood Glucose ; Fatty Acids ; Glucagon-Like Peptide-1 Receptor ; Triglycerides ; Gastric Inhibitory Polypeptide (59392-49-3) ; Liraglutide (839I73S42A) ; Glucagon-Like Peptide 1 (89750-14-1) ; Glucose (IY9XDZ35W2)
Language	English
Publishing date	2021-03-31
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	1932-6203
ISSN (online)	1932-6203
DOI	10.1371/journal.pone.0249239
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Chronic peptide-based GIP receptor inhibition exhibits modest glucose metabolic changes in mice when administered either alone or combined with GLP-1 agonism.

Jason A West / Anastasia Tsakmaki / Soumitra S Ghosh / David G Parkes / Rikke V Grønlund / Philip J Pedersen / David Maggs / Harith Rajagopalan / Gavin A Bewick

PLoS ONE, Vol 16, Iss 3, p e

2021 Volume 0249239

Abstract	Combinatorial gut hormone therapy is one of the more promising strategies for identifying improved treatments for metabolic disease. Many approaches combine the established benefits of glucagon-like peptide-1 (GLP-1) agonism with one or more additional molecules with the aim of improving metabolic outcomes. Recent attention has been drawn to the glucose-dependent insulinotropic polypeptide (GIP) system due to compelling pre-clinical evidence describing the metabolic benefits of antagonising the GIP receptor (GIPR). We rationalised that benefit might be accrued from combining GIPR antagonism with GLP-1 agonism. Two GIPR peptide antagonists, GIPA-1 (mouse GIP(3-30)NH2) and GIPA-2 (NαAc-K10[γEγE-C16]-Arg18-hGIP(5-42)), were pharmacologically characterised and both exhibited potent antagonist properties. Acute in vivo administration of GIPA-1 during an oral glucose tolerance test (OGTT) had negligible effects on glucose tolerance and insulin in lean mice. In contrast, GIPA-2 impaired glucose tolerance and attenuated circulating insulin levels. A mouse model of diet-induced obesity (DIO) was used to investigate the potential metabolic benefits of chronic dosing of each antagonist, alone or in combination with liraglutide. Chronic administration studies showed expected effects of liraglutide, lowering food intake, body weight, fasting blood glucose and plasma insulin concentrations while improving glucose sensitivity, whereas delivery of either GIPR antagonist alone had negligible effects on these parameters. Interestingly, chronic dual therapy augmented insulin sensitizing effects and lowered plasma triglycerides and free-fatty acids, with more notable effects observed with GIPA-1 compared to GIPA-2. Thus, the co-administration of both a GIPR antagonist with a GLP1 agonist uncovers interesting beneficial effects on measures of insulin sensitivity, circulating lipids and certain adipose stores that seem influenced by the degree or nature of GIP receptor antagonism.
Keywords	Medicine ; R ; Science ; Q
Subject code	610
Language	English
Publishing date	2021-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Durable metabolic improvements 2 years after duodenal mucosal resurfacing (DMR) in patients with type 2 diabetes (REVITA-1 Study).

Diabetes research and clinical practice

2022 Volume 184, Page(s) 109194

Abstract: Aims: Duodenal mucosal resurfacing (DMR) is an endoscopic procedure developed to improve metabolic parameters and restore insulin sensitivity in patients with diabetes. Here we report long-term DMR safety and efficacy from the REVITA-1 study.: ... ...

Abstract	Aims: Duodenal mucosal resurfacing (DMR) is an endoscopic procedure developed to improve metabolic parameters and restore insulin sensitivity in patients with diabetes. Here we report long-term DMR safety and efficacy from the REVITA-1 study. Materials and methods: REVITA-1 was a prospective, single-arm, open-label, multicenter study of DMR feasibility, safety, and efficacy in patients with type 2 diabetes (hemoglobin A1c [HbA1c] of 7.5-10.0% (58-86 mmol/mol)) on oral medication. Safety and glycemic (HbA1c), hepatic (alanine aminotransferase [ALT]), and cardiovascular (HDL, triglyceride [TG]/HDL ratio) efficacy parameters were assessed (P values presented for LS mean change). Results: Mean ± SD HbA1c levels reduced from 8.5 ± 0.7% (69.1 ± 7.1 mmol/mol) at baseline (N = 34) to 7.5 ± 0.8% (58.9 ± 8.8 mmol/mol) at 6 months (P < 0.001); and this reduction was sustained through 24 months post-DMR (7.5 ± 1.1% [59.0 ± 12.3 mmol/mol], P < 0.001) while in greater than 50% of patients, glucose-lowering therapy was reduced or unchanged. ALT decreased from 38.1 ± 21.1 U/L at baseline to 32.5 ± 22.1 U/L at 24 months (P = 0.048). HDL and TG/HDL improved during 24-months of follow-up. No device- or procedure-related serious adverse events, unanticipated device effects, or hypoglycemic events were noted between 12 and 24 months post-DMR. Conclusions: DMR is associated with durable improvements in insulin sensitivity and multiple downstream metabolic parameters through 24 months post-treatment in type 2 diabetes. Clinical trial reg. no. NCT02413567, clinicaltrials.gov.
MeSH term(s)	Blood Glucose/metabolism ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/surgery ; Duodenum/chemistry ; Duodenum/metabolism ; Duodenum/surgery ; Glycated Hemoglobin A/analysis ; Humans ; Hypoglycemic Agents/therapeutic use ; Prospective Studies ; Treatment Outcome
Chemical Substances	Blood Glucose ; Glycated Hemoglobin A ; Hypoglycemic Agents
Language	English
Publishing date	2022-01-13
Publishing country	Ireland
Document type	Clinical Trial ; Journal Article ; Multicenter Study
ZDB-ID	632523-3
ISSN	1872-8227 ; 0168-8227
ISSN (online)	1872-8227
ISSN	0168-8227
DOI	10.1016/j.diabres.2022.109194
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Article ; Online: Duodenal mucosal resurfacing: proof-of-concept, procedural development, and initial implementation in the clinical setting.

Haidry, Rehan J / van Baar, Annieke C / Galvao Neto, Manoel P / Rajagopalan, Harith / Caplan, Jay / Levin, Philip S / Bergman, Jacques J / Rodriguez, Leonardo / Deviere, Jacques / Thompson, Christopher C

Gastrointestinal endoscopy

2019 Volume 90, Issue 4, Page(s) 673–681.e2

Abstract: Background and aims: We aimed to develop duodenal mucosal resurfacing (DMR), a minimally invasive upper endoscopic hydrothermal ablation procedure, to treat insulin-resistant metabolic diseases.: Methods: We completed a sham-controlled, rodent proof- ... ...

Abstract	Background and aims: We aimed to develop duodenal mucosal resurfacing (DMR), a minimally invasive upper endoscopic hydrothermal ablation procedure, to treat insulin-resistant metabolic diseases. Methods: We completed a sham-controlled, rodent proof-of-concept study and longitudinal safety study in pigs to demonstrate feasibility to test DMR in humans. Subsequently, the DMR procedure was implemented in an open-label first-in-human (FIH) study of safety and efficacy in patients with type 2 diabetes (T2D). Results: In rats, duodenal abrasion reduced hyperglycemia by 59 mg/dL on average, compared with no change from baseline in the sham treatment arm (P < .05). In pigs, the balloon catheter successfully and safely delivered hydrothermal ablation to the duodenal mucosa and superficial submucosa. Complete mucosal healing was demonstrated by week 6. In the FIH study, hydrothermal ablation was successfully administered with no evidence of perforation, pancreatitis, or hemorrhage. Duodenal biopsy specimens obtained 3 months postprocedure demonstrated full mucosal regrowth. No inflammation was observed, and there was minimal-to-mild collagen banding deposition observed in a proportion of ablation site biopsy specimens with no evidence of fibrotic scarring. Glycemic and hepatic measures improved through 6 months of follow-up. Conclusions: DMR shows potential as an endoscopic intervention that improves glycemic and hepatic parameters in patients with T2D. Further mechanistic and clinical studies are underway to further explore DMR as a treatment for metabolic disease.
MeSH term(s)	Ablation Techniques/methods ; Alanine Transaminase/metabolism ; Animals ; Aspartate Aminotransferases/metabolism ; Blood Glucose/metabolism ; Constriction, Pathologic ; Diabetes Mellitus, Type 2/metabolism ; Diabetes Mellitus, Type 2/therapy ; Disease Models, Animal ; Duodenoscopy/methods ; Duodenum/pathology ; Duodenum/surgery ; Glycated Hemoglobin A/metabolism ; Humans ; Intestinal Mucosa/pathology ; Intestinal Mucosa/surgery ; Non-alcoholic Fatty Liver Disease/metabolism ; Non-alcoholic Fatty Liver Disease/therapy ; Pancreatitis/epidemiology ; Postoperative Complications/epidemiology ; Postoperative Hemorrhage/epidemiology ; Proof of Concept Study ; Rats ; Sus scrofa ; Swine
Chemical Substances	Blood Glucose ; Glycated Hemoglobin A ; hemoglobin A1c protein, human ; Aspartate Aminotransferases (EC 2.6.1.1) ; Alanine Transaminase (EC 2.6.1.2)
Language	English
Publishing date	2019-03-29
Publishing country	United States
Document type	Journal Article
ZDB-ID	391583-9
ISSN	1097-6779 ; 0016-5107
ISSN (online)	1097-6779
ISSN	0016-5107
DOI	10.1016/j.gie.2019.03.024
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Article: CIN-ful cancers.

Rajagopalan, Harith / Lengauer, Christoph

Cancer chemotherapy and pharmacology

2004 Volume 54 Suppl 1, Page(s) S65–8

Abstract: Aneuploidy has long been recognized to be a cardinal feature of many neoplasias. However, the role of aneuploidy in tumorigenesis continues to be a matter of debate. We believe that aneuploidy in cancers is the result of chromosomal instability, a ... ...

Abstract	Aneuploidy has long been recognized to be a cardinal feature of many neoplasias. However, the role of aneuploidy in tumorigenesis continues to be a matter of debate. We believe that aneuploidy in cancers is the result of chromosomal instability, a process in which dividing cancer cells segregate their chromosomes with decreased fidelity. Here we discuss our definition of chromosomal instability, evidence for its causal role in tumor development, and suggestions regarding the mechanisms that initiate chromosomal instability in cancer cells.
MeSH term(s)	Aneuploidy ; Cell Cycle ; Chromosomal Instability ; Humans ; Neoplasms/genetics
Language	English
Publishing date	2004-09
Publishing country	Germany
Document type	Journal Article
ZDB-ID	6820-2
ISSN	1432-0843 ; 0344-5704 ; 0943-9404
ISSN (online)	1432-0843
ISSN	0344-5704 ; 0943-9404
DOI	10.1007/s00280-004-0889-8
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