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Bed Rest, Alternate Daily Fasting and Incretin Effect

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Rigshospitalet

Status

Completed

Conditions

Critical Illness
Type 2 Diabetes
Metabolic Syndrome

Treatments

Other: IVGTT
Other: Muscle and fat biopsies
Other: MRI
Other: Dual-energy X-ray Absorptiometry (DXA) scan
Other: Bed rest
Other: OGTT
Other: Cognitive testing

Study type

Interventional

Funder types

Other

Identifiers

NCT02134860
H-6-2014-017

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

Male

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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