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NCT Number: NCT02134860

Bed Rest, Alternate Daily Fasting and Incretin Effect

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

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Key information

Conditions

Metabolic Syndrome Critical Illness Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Type 2 Diabetes

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bed Rest

Other

8 days of full bed rest

OGTT

Other

Oral glucose tolerance test with 75 g of glucose before and after bed rest

IVGTT

Other

Intravenous glucose tolerance test mimicking the glucose profile from the corresponding OGTT

Cognitive testing

Other

Daily testing of memory and concentration using standardized tests

Muscle and fat biopsies

Other

Biopsies will be obtained before and after bed rest

Dual-energy X-ray Absorptiometry (DXA) scan

Other

DXA scan to evaluate fat and muscle distribution before and after bed rest

MRI

Other

Functional MRI to evaluate cognitive function and abdominal MRI to evaluate visceral fat before and after bed rest

Primary outcomes

  1. Incretin effect

    Time frame: 24 weeks

    Measured by Insulin levels during Oral glucose tolerance test (OGTT) and Intravenous glucose tolerance test (IVGTT)

  2. Cognitive function

    Time frame: 18 months

    Evaluated by cognitive testing and functional Magnetic Resonance imaging (MRI)

  3. Insulin resistance

    Time frame: 12 weeks

    Evaluated by insulin resistance indexes, HOMA-IR and Matsuda index

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 9, 2014
Registry last updated
Sep 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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