GIP/GLP-1 Co-Activity in Subjects With Overweight and Type 2 Diabetes: Lowering of Food Intake

NCT ID: NCT03526289

Last Updated: 2018-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-08
• Study Completion Date: 2018-10-24

Brief Summary

The primary aim of the study is to evaluate how GIP receptor activation influence food intake and mechanisms regulating food intake in obese individuals with type 2 diabetes that are in steady treatment with metformin and a GLP-1 receptor agonist.

Detailed Description

The study is designed as a double blinded cross-over study with two study days: One day of GIP infusion (for 5 hours) and one day with placebo (saline) infusion (for 5 hours). The primary endpoint is difference in food intake between the two study days. Food intake is examined as amount of food eaten during an ad libitum meal.

Conditions

Type 2 Diabetes Mellitus; Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

GIP infusion

5 hours of continuously GIP1-42 infusion

Group Type: ACTIVE_COMPARATOR

GIP1-42 infusion

Intervention Type: BIOLOGICAL

5-hour GIP1-42 infusion (time point 0-300 minutes)

Saline

5 hours of continuously saline infusion

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: OTHER

5-hour infusion of saline (placebo) (time point 0-300 minutes)

Interventions

GIP1-42 infusion

5-hour GIP1-42 infusion (time point 0-300 minutes)

Intervention Type: BIOLOGICAL

Saline

5-hour infusion of saline (placebo) (time point 0-300 minutes)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Caucasian men
• Age between 18 and 70 years
• Body mass index (BMI) between 25 and 40 kg/m2
• Type 2 diabetes (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mM (<8.5 %)
• In stable treatment for ≥3 months with metformin ≥1 g and a GLP-1 receptor agonist.
• Informed consent

Exclusion Criteria

• Anaemia (haemoglobin outside normal range)
• Any current or prior gastrointestinal disease that may interfere with the endpoint variables
• Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) > 2 times normal values) or history of hepatobiliary disorder.
• Nephropathy (serum creatinine above normal range and/or albuminuria).
• Anorexia, bulimia or binge eating disorder
• Allergy or intolerance to ingredients included in the standardised meals
• Tobacco smoking
• Treatment with other glucose lowering drugs than GLP-1 receptor agonists and metformin.
• Any regular drug treatment (besides metformin and GLP-1 receptor agonists) that cannot be discontinued for a minimum of 12 hours
• Any physical or psychological condition that the investigator feels would interfere with trial participation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Zealand Pharma

INDUSTRY

Sponsor Role: collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Natasha Chidekel Bergmann

Medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for diabetes research

Hellerup, , Denmark

Countries

Denmark

References

Bergmann NC, Gasbjerg LS, Heimburger SM, Krogh LSL, Dela F, Hartmann B, Holst JJ, Jessen L, Christensen MB, Vilsboll T, Lund A, Knop FK. No Acute Effects of Exogenous Glucose-Dependent Insulinotropic Polypeptide on Energy Intake, Appetite, or Energy Expenditure When Added to Treatment With a Long-Acting Glucagon-Like Peptide 1 Receptor Agonist in Men With Type 2 Diabetes. Diabetes Care. 2020 Mar;43(3):588-596. doi: 10.2337/dc19-0578. Epub 2020 Jan 16.

Reference Type: DERIVED

PMID: 31949084 (View on PubMed)

Other Identifiers

H-16031728

Identifier Type: -

Identifier Source: org_study_id