Insulinotropic Effect of GIP and GLP-1 Before and After Reduced Glucose Tolerance

Not Applicable

Completed

• Conditions: Insulin Resistance; Deteriorated Glucose Homeostasis; Inactivity
• Interventions: Other: No intervention; Behavioral: Steroid hormone

• Registration Number: NCT01173978
• Lead Sponsor: Glostrup University Hospital, Copenhagen

Brief Summary

The incretin effect in patients with type two diabetes is reduced. The investigators have previously shown that it is possible to induce a defect in the incretin effect in healthy individuals. The purpose of this study is to evaluate the insulinotropic affect of the incretin hormones in healthy individuals before and after a deterioration of the glucose homeostasis.

Detailed Description

The incretin effect in patients with type two diabetes is reduced. The investigators have previously shown that it is possible to induce a defect in the incretin effect in healthy individuals. The purpose of this study is to evaluate the insulinotropic affect of the incretin hormones in healthy individuals before and after a deterioration of the glucose homeostasis. The evaluation is done by infusing GIP, GLP-1 or saline during hyperglycemic clamps.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-06-07
• Status Verified: 2010-07
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted QC: 2010-08-02
• Study First Posted: 2010-08-03
• Last Update Submitted: 2011-06-20
• Last Update Posted: 2011-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

• Caucasians without type 2 diabetes mellitus
• Normal OGTT (75 g of glucose) according to WHO's criteria
• BMI 20-30
• Hemoglobin > 8.0 mmol/l
• Informed consent

Exclusion Criteria

• Liver disease (ALAT > 2 x normal level)
• Nephropathy (s-creatinin > 130 µM or albuminuria)
• Relatives (parents/siblings) with T2DM
• Medical treatment witch cannot be stopped for 12 hours

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
No intervention	No intervention	Each participant is examined during a normal, active lifestyle, without any intervention: The examinations include an OGTT, a glucagon test, three hyperglycemic clamps with infusion of a)GLP-1; b)GIP; c)Nacl
Intervention	Steroid hormone	Each participant is examined during a 12 days intervention.The examinations include an OGTT, a glucagon test, three hyperglycemic clamps with infusion of a)GLP-1; b)GIP; c)Nacl

Primary Outcome Measures

Name	Time	Method
Insulinotropic effect of incretin hormones	12 days	Measurements of the insulinotropic effect of incretin hormones before and after 12 days intervention with steroid treatment, high calorie diet and relative physical inactivity

Secondary Outcome Measures

Name	Time	Method
Plasma concentration of glucagon	12 days	Measurements of plasma concentration of glucagon before and after 12 days intervention with steroid treatment, high calorie diet and relative physical inactivity

Trial Locations

Locations (1)

Department of Clinical Physiology; 🇩🇰 Glostrup, Denmark