Bed Rest, Alternate Daily Fasting and Incretin Effect
NCT02134860 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2014-09-22
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
Conditions
- Metabolic Syndrome
- Type 2 Diabetes
- Critical Illness
Interventions
- OTHER
-
Bed rest
8 days of full bed rest
- OTHER
-
OGTT
Oral glucose tolerance test with 75 g of glucose before and after bed rest
- OTHER
-
IVGTT
Intravenous glucose tolerance test mimicking the glucose profile from the corresponding OGTT
- OTHER
-
Cognitive testing
Daily testing of memory and concentration using standardized tests
- OTHER
-
Muscle and fat biopsies
Biopsies will be obtained before and after bed rest
- OTHER
-
Dual-energy X-ray Absorptiometry (DXA) scan
DXA scan to evaluate fat and muscle distribution before and after bed rest
- OTHER
-
MRI
Functional MRI to evaluate cognitive function and abdominal MRI to evaluate visceral fat before and after bed rest
Sponsors & Collaborators
-
Rigshospitalet, Denmark
lead OTHER
Principal Investigators
-
Nina Majlund Harder-Lauridsen, MD · Rigshospitalet, 7641
-
Signe Tellerup Nielsen, MD · Rigshospitalet, 7641
-
Rikke Krogh-Madsen, MD. PhD · Rigshospitalet, 7641
-
Bente Klarlund Pedersen, Professor · Rigshospitalet, 7641
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 35 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-06-30
- Primary Completion
- 2014-09-30
- Completion
- 2014-09-30
Countries
- Denmark
Study Locations
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