Bed Rest, Alternate Daily Fasting and Incretin Effect

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Type 2 Diabetes; Critical Illness
• Interventions: Other: Bed rest; Other: OGTT; Other: IVGTT; Other: Cognitive testing; Other: Muscle and fat biopsies; Other: Dual-energy X-ray Absorptiometry (DXA) scan; Other: MRI

• Registration Number: NCT02134860
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2014-04-29
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-09
• Study Start: 2014-06
• Status Verified: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2014-09-19
• Last Update Posted: 2014-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isocaloric diet	OGTT	3 daily meals
Alternate daily fasting	MRI	One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day
Isocaloric diet	Dual-energy X-ray Absorptiometry (DXA) scan	3 daily meals
Alternate daily fasting	IVGTT	One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day
Alternate daily fasting	Muscle and fat biopsies	One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day
Isocaloric diet	Bed rest	3 daily meals
Isocaloric diet	IVGTT	3 daily meals
Isocaloric diet	Cognitive testing	3 daily meals
Isocaloric diet	Muscle and fat biopsies	3 daily meals
Isocaloric diet	MRI	3 daily meals
Alternate daily fasting	Bed rest	One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day
Alternate daily fasting	Cognitive testing	One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day
Alternate daily fasting	OGTT	One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day
Alternate daily fasting	Dual-energy X-ray Absorptiometry (DXA) scan	One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day

Primary Outcome Measures

Name	Time	Method
Cognitive function	18 months	Evaluated by cognitive testing and functional Magnetic Resonance imaging (MRI)
Incretin effect	24 weeks	Measured by Insulin levels during Oral glucose tolerance test (OGTT) and Intravenous glucose tolerance test (IVGTT)
Insulin resistance	12 weeks	Evaluated by insulin resistance indexes, HOMA-IR and Matsuda index

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark