Bed Rest, Alternate Daily Fasting and Incretin Effect

Type 2 Diabetes Clinical Trial

Official title:

A Randomized Controlled Study on the Incretin Effect, Cognitive Function and Controlled Fasting During Bed Rest in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134860
• Other study ID #: H-6-2014-017
• Status: Completed
• Phase: N/A
• First received: April 29, 2014
• Last updated: September 19, 2014
• Start date: June 2014
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

Bed rest produces insulin resistance in healthy volunteers. In this study the investigators aim to investigate the effect of 8 days bed rest on the incretin effect and how alternate daily fasting affects cognitive function and the insulin resistance produced by bed rest.

The subjects will be randomized to either 3 meals a day (isocaloric diet), alternate daily fasting or one meal/day every second day (25% of daily calorie need) and four meals/day every second (175% of daily calorie need).

The investigators hypothesize:

1. Bed rest reduces the incretin effect

2. Alternate daily fasting improves the cognitive function (memory and concentration) compared to isocaloric diet

3. Alternate daily fasting reduces insulin resistance produced by bed rest compared to isocaloric diet

Description:

All subjects will undergo 8 days of bedrest. Outcome measures will be performed before, under and immediately after the bed rest period.

The individual study period will be 10 days in total.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• BMI<25kg/m2

• VO2 max normal for age

Exclusion Criteria:

• Tobacco smoking

• Alcohol ingestion > 14 units per week

• Diabetes in nearby relatives

• Resection of the small intestine

• History of gastric bypass surgery

• Risk of deep venous thrombosis

• Female

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Critical Illness
• Metabolic Syndrome
• Metabolic Syndrome X
• Type 2 Diabetes

Intervention

Other:
• Bed rest
8 days of full bed rest
• OGTT
Oral glucose tolerance test with 75 g of glucose before and after bed rest
• IVGTT
Intravenous glucose tolerance test mimicking the glucose profile from the corresponding OGTT
• Cognitive testing
Daily testing of memory and concentration using standardized tests
• Muscle and fat biopsies
Biopsies will be obtained before and after bed rest
• Dual-energy X-ray Absorptiometry (DXA) scan
DXA scan to evaluate fat and muscle distribution before and after bed rest
• MRI
Functional MRI to evaluate cognitive function and abdominal MRI to evaluate visceral fat before and after bed rest

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incretin effect	Measured by Insulin levels during Oral glucose tolerance test (OGTT) and Intravenous glucose tolerance test (IVGTT)	24 weeks	No
Primary	Cognitive function	Evaluated by cognitive testing and functional Magnetic Resonance imaging (MRI)	18 months	No
Primary	Insulin resistance	Evaluated by insulin resistance indexes, HOMA-IR and Matsuda index	12 weeks	No