Interest of GLP1 Analogues in Overweight Type 2 Diabetic Patients With Chronic Inflammatory Bowel Disease (DiagMICI)

March 6, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

Interest of GLP1 Analogues (aGLP1) in Overweight Type 2 Diabetic Patients With Chronic Inflammatory Bowel Disease (IBD)

The risk of type 2 diabetes appears to be higher in patients with chronic inflammatory diseases, including chronic inflammatory bowel disease (IBD). IBD is a group of inflammatory diseases that includes mainly Crohn's disease and ulcerative colitis.

Although the majority of IBD patients are not overweight, the prevalence of obesity in this population remains significant, estimated at 15 to 40%. It has been shown that obesity can impact the response to therapies used in IBD as well as the clinical course of the disease:

1) plasma concentrations of immunomodulatory therapies are often lower in the obese compared to those with a normal Body Mass Index (BMI) with a lower dose per kg of the administered drug as well as an acceleration of drug clearance.

2nd) Surgical management of IBD is associated with a higher risk of peri- and post-operative complications in obese patients, including an increase in operating time, bleeding risk, length of hospital stay and percentage of post-operative infections.

3e) Finally, obesity seems to have a negative impact on the clinical course of IBD, with a correlation between an increase in BMI and an increase in the number of hospitalizations, the number of follow-up consultations and the need for therapeutic escalation.

One of the common pathophysiological explanations between IBD and metabolic syndrome (including type 2 diabetes and obesity), would involve metabolites in the gut that are modulated by the gut microbiota.

Glucagon-Like Peptide 1 (aGLP1) analogues are a new class of injectable antidiabetic drugs that have revolutionized the management of type 2 diabetes. They include exenatide, lixisenatide, liraglutide, dulaglutide and semaglutide. They combine an effect on glycemic control but also usually a weight loss. In some countries, they are used in non-diabetic obese patients, with a weight loss of up to -10 to -15%. These molecules bind to GLP1 receptors, stimulate insulin secretion when blood glucose levels are high, decrease glucagon secretion, slow gastric emptying and stimulate satiety. In addition to glycemic control, weight reduction is most often associated.

In addition, some aGLP1s have been shown to reduce cardiovascular events in diabetics. They are well tolerated, but their side effects are mainly digestive, such as nausea, vomiting and sometimes diarrhea. These problems occur in about 20% of cases, most often after the first injection, with vomiting requiring permanent cessation of treatment. Most often they gradually subside, spontaneously or after symptomatic treatment, and allow titration of the drug.

Due to the lack of studies and possible intestinal effects, aGLP1 is not recommended in cases of severe gastrointestinal disease, and therefore in cases of IBD, although it is not contraindicated.

The main objective of this study is to test the interest of these GLP1 analogues in type 2 diabetics with IBD, who are overweight and whose glycemic target is not reached. The expected benefit is to facilitate diabetes control and weight loss in this population. The second objective is to monitor the occurrence of adverse events in this population with the different GLP1 analogues used.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75014
        • Recruiting
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Patients between 18 and 75 years of age
  • Patients with inflammatory bowel disease (Crohn's disease (CD) or ulcerative colitis (UC))
  • Patient with poorly controlled type 2 diabetes (defined as deviation from the set glycemic target of more than 1% HbA1c)
  • Patient with a BMI ≥ 25 kg/m2

  • For women of childbearing age: effective contraception* during treatment and up to 5 weeks after discontinuation

    * Any contraceptive method used regularly and appropriately that has a low failure rate (i.e., less than 1% per year)

  • Patient enrolled in a health insurance plan
  • Francophone patient
  • Patient with free, informed, written consent

Exclusion Criteria:

  • Patient with a personal or family history of medullary thyroid cancer
  • Patient with an active cancer
  • Patient with a history of acute or chronic pancreatitis
  • Patients with a history of hypersensitivity to GLP1 analogues (or to any other component of the product)
  • Patient with a history of severe GI intolerance to GLP-1 receptor agonists
  • Patient already included in a risky interventional research protocol (RIPH1)
  • Pregnant or breastfeeding women
  • Patients with congestive heart failure New York Heart Association (NYHA) class IV
  • Patient with end-stage renal disease
  • Patients with clinically significant sustained elevation of resting heart rate
  • Patient with anti-GAD antibodies in a previous workup at inclusion
  • Patient under guardianship or curatorship
  • Patient under court protection
  • Patient deprived of liberty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GLP1 analogues
This cohort study has 2 phases: an observation phase to collect all initial clinical and biological parameters and an intervention phase (prescription of GLP1 analogues) of 6 months including a visit at 3 and 6 months.
Other: GLP1 analogues
This cohort study has 2 phases: an observation phase to collect all initial clinical and biological parameters and an intervention phase (prescription of GLP1 analogues) of 6 months including a visit at 3 and 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: Month 6
This outcome corresponds to the Change in HbA1c at 3 and 6 months compared with baseline at initiation of therapy.
Month 6
Weight loss
Time Frame: Month 6
This outcome corresponds to the weight reducation at 3 and 6 months compared to baseline.
Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance of GLP1 analogues after 3 months of treatment
Time Frame: Month 3
This outcome corresponds to th number of serious and non-serious adverse events after 3 months of treatment with aGLP1.
Month 3
Tolerance of GLP1 analogues after 6 months of treatment tolerance of GLP1 analogues after 3 and 6 months of treatment
Time Frame: Month 6
This outcome corresponds to the number of serious and non-serious adverse events after 6 months of treatment with aGLP1.
Month 6
Quality of life after 3 months of treatment
Time Frame: Month 3
This outcome corresponds to the Quality of life of patients according to the Inflammatory Bowel Disease Questionnaire score. It includes 32 items in four domains: digestive symptoms (10 items), systemic symptoms (5 items), emotional disorders (12 items), social function (5 items). Each item is measured using the Likert technique. For each item, the interviewer presents a set of 7 statements describing an attitude. To each degree of agreement, a numerical value (from 1 to 7) is attached. In this way, by adding the individual scores, a total numerical value can be calculated. The total score ranges from 32 to 224, the higher the score the better the quality of life. This index has been validated and is correlated with the different disease activity scores.
Month 3
Quality of life after 6 months of treatment
Time Frame: Month 6
This outcome corresponds to the Quality of life of patients according to the Inflammatory Bowel Disease Questionnaire score. It includes 32 items in four domains: digestive symptoms (10 items), systemic symptoms (5 items), emotional disorders (12 items), social function (5 items). Each item is measured using the Likert technique. For each item, the interviewer presents a set of 7 statements describing an attitude. To each degree of agreement, a numerical value (from 1 to 7) is attached. In this way, by adding the individual scores, a total numerical value can be calculated. The total score ranges from 32 to 224, the higher the score the better the quality of life. This index has been validated and is correlated with the different disease activity scores.
Month 6
Impact of aGLP1 on the treatment already in place to regulate blood glucose
Time Frame: Month 6
This outcome corresponds to the reduction in number/dose of anti-diabetic medications or daily insulin dose.
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Adela VOICAN, MD, Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2022

Primary Completion (Anticipated)

January 14, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

December 30, 2021

First Submitted That Met QC Criteria

January 18, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DiagMICI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on GLP1 analogues

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe