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

Insulin Resistance Clinical Trial

Official title:

Insulinotropic Effect of GIP and GLP-1 Before and After Reduced Glucose Induced by Steroid Treatment, Relative Physical Inactivity and High Calorie Diet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01173978
• Other study ID #: DYS-CLAMP
• Status: Completed
• Phase: N/A
• First received: June 7, 2010
• Last updated: June 20, 2011
• Start date: April 2010
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of HealthDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Deteriorated Glucose Homeostasis
• Inactivity
• Insulin Resistance

Intervention

Behavioral:
• Steroid hormone
Steroid hormone: 37,5 mg of prednisolone; High energy diet: 130 % of recommended daily energy intake; Relative physical inactivity: no exercise and at least 8 hours of rest/day

Other:
• No intervention

Locations

Country	Name	City	State
Denmark	Department of Clinical Physiology	Glostrup

Sponsors (3)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	European Foundation for the Study of Diabetes, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulinotropic effect of incretin hormones	Measurements of the insulinotropic effect of incretin hormones before and after 12 days intervention with steroid treatment, high calorie diet and relative physical inactivity	12 days	No
Secondary	Plasma concentration of glucagon	Measurements of plasma concentration of glucagon before and after 12 days intervention with steroid treatment, high calorie diet and relative physical inactivity	12 days	No