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Bed Rest, Alternate Daily Fasting and Incretin Effect

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ClinicalTrials.gov Identifier: NCT02134860
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : September 22, 2014
Sponsor:
Information provided by (Responsible Party):
Anders Rasmussen Rinnov, Rigshospitalet, Denmark

Study Description
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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

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Type 2 Diabetes Critical Illness 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 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized Controlled Study on the Incretin Effect, Cognitive Function and Controlled Fasting During Bed Rest in Healthy Male Volunteers
Study Start Date : June 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Isocaloric diet
3 daily meals
 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
Active Comparator: Alternate daily fasting
One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day
 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


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134860


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Nina Majlund Harder-Lauridsen, MD Rigshospitalet, 7641
Principal Investigator: Signe Tellerup Nielsen, MD Rigshospitalet, 7641
Principal Investigator: Rikke Krogh-Madsen, MD. PhD Rigshospitalet, 7641
Study Director: Bente Klarlund Pedersen, Professor Rigshospitalet, 7641
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Anders Rasmussen Rinnov, MD, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02134860    
Other Study ID Numbers: H-6-2014-017
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: September 22, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Metabolic Syndrome
Critical Illness
Insulin Resistance
Hyperinsulinism
 Glucose Metabolism Disorders
Metabolic Diseases
Disease Attributes
Pathologic Processes