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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Overweight and Obesity
• Interventions: Other: Saline; Biological: GIP1-42 infusion

• Registration Number: NCT03526289
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

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.

Study Timeline

• Study First Submitted: 2017-10-24
• Study Start: 2017-11-08
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-16
• Primary Completion: 2018-10-24
• Study Completion: 2018-10-24
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-04
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline	Saline	5 hours of continuously saline infusion
GIP infusion	GIP1-42 infusion	5 hours of continuously GIP1-42 infusion

Primary Outcome Measures

Name	Time	Method
food intake	time point 300-330 minutes	food intake (kJ) eaten from an ad libitum meal of pasta bolognese

Secondary Outcome Measures

Name	Time	Method
Energy expenditure	measured at baseline and at time point 250 minutes	resting energy expenditure measured by indirect calorimetry (kcal/day)
prospective food consumption	time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes	prospective food consumption rated on visual analogue scales (0-10 mm)
Nausea	time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes	Nausea rated on visual analogue scales (0-10 mm)
Insulin responses	at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes	blood samples
Appetite	time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes	Appetite rated on visual analogue scales (0-10 mm)
Thirst	time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes	Thirst rated on visual analogue scales (0-10 mm)
gastric emptying	ingested at time point -15, 0, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes	acetaminophen test
glucagon responses	at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes	blood samples
satiety	time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes	Satiety rated on visual analogue scales (0-10 mm)
fullness	time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes	fullness rated on visual analogue scales (0-10 mm)
gallbladder emptying	at time point -15, 0, 30, 60, 90, 120, 150, 180, 240 minutes	gallbladder emptying evaluated by ultrasound
C-peptide responses	at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes	blood samples
gut hormone responses	at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes	Blood samples
bone turnover markers	at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes	Blood samples

Trial Locations

Locations (1)

Center for diabetes research; 🇩🇰 Hellerup, Denmark