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

Type 2 Diabetes Mellitus Clinical Trial

— GASOLIN II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03526289
• Other study ID #: H-16031728
• Status: Completed
• Phase: N/A
• Start date: November 8, 2017
• Est. completion date: October 24, 2018

Study information

• Verified date: December 2018
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 24, 2018
• Est. primary completion date: October 24, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Overweight
• Overweight and Obesity
• Type 2 Diabetes Mellitus

Intervention

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

Other:
• Saline
5-hour infusion of saline (placebo) (time point 0-300 minutes)

Locations

Country	Name	City	State
Denmark	Center for diabetes research	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	Zealand Pharma

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	food intake	food intake (kJ) eaten from an ad libitum meal of pasta bolognese	time point 300-330 minutes
Secondary	Appetite	Appetite rated on visual analogue scales (0-10 mm)	time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
Secondary	satiety	Satiety rated on visual analogue scales (0-10 mm)	time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
Secondary	prospective food consumption	prospective food consumption rated on visual analogue scales (0-10 mm)	time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
Secondary	fullness	fullness rated on visual analogue scales (0-10 mm)	time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
Secondary	Thirst	Thirst rated on visual analogue scales (0-10 mm)	time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
Secondary	Nausea	Nausea rated on visual analogue scales (0-10 mm)	time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
Secondary	Energy expenditure	resting energy expenditure measured by indirect calorimetry (kcal/day)	measured at baseline and at time point 250 minutes
Secondary	gastric emptying	acetaminophen test	ingested at time point -15, 0, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
Secondary	gallbladder emptying	gallbladder emptying evaluated by ultrasound	at time point -15, 0, 30, 60, 90, 120, 150, 180, 240 minutes
Secondary	glucagon responses	blood samples	at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
Secondary	Insulin responses	blood samples	at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
Secondary	C-peptide responses	blood samples	at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
Secondary	gut hormone responses	Blood samples	at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
Secondary	bone turnover markers	Blood samples	at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes