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Bed Rest, Alternate Daily Fasting and Incretin Effect

Primary Purpose

Metabolic Syndrome, Type 2 Diabetes, Critical Illness

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Bed rest
OGTT
IVGTT
Cognitive testing
Muscle and fat biopsies
Dual-energy X-ray Absorptiometry (DXA) scan
MRI
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts 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

Sites / Locations

  • Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Isocaloric diet

Alternate daily fasting

Arm Description

3 daily meals

One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 29, 2014
Last Updated
September 19, 2014
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02134860
Brief Title
Bed Rest, Alternate Daily Fasting and Incretin Effect
Official Title
A Randomized Controlled Study on the Incretin Effect, Cognitive Function and Controlled Fasting During Bed Rest in Healthy Male Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Bed rest reduces the incretin effect Alternate daily fasting improves the cognitive function (memory and concentration) compared to isocaloric diet 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Type 2 Diabetes, Critical Illness

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isocaloric diet
Arm Type
Active Comparator
Arm Description
3 daily meals
Arm Title
Alternate daily fasting
Arm Type
Active Comparator
Arm Description
One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day
Intervention Type
Other
Intervention Name(s)
Bed rest
Intervention Description
8 days of full bed rest
Intervention Type
Other
Intervention Name(s)
OGTT
Intervention Description
Oral glucose tolerance test with 75 g of glucose before and after bed rest
Intervention Type
Other
Intervention Name(s)
IVGTT
Intervention Description
Intravenous glucose tolerance test mimicking the glucose profile from the corresponding OGTT
Intervention Type
Other
Intervention Name(s)
Cognitive testing
Intervention Description
Daily testing of memory and concentration using standardized tests
Intervention Type
Other
Intervention Name(s)
Muscle and fat biopsies
Intervention Description
Biopsies will be obtained before and after bed rest
Intervention Type
Other
Intervention Name(s)
Dual-energy X-ray Absorptiometry (DXA) scan
Intervention Description
DXA scan to evaluate fat and muscle distribution before and after bed rest
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
Functional MRI to evaluate cognitive function and abdominal MRI to evaluate visceral fat before and after bed rest
Primary Outcome Measure Information:
Title
Incretin effect
Description
Measured by Insulin levels during Oral glucose tolerance test (OGTT) and Intravenous glucose tolerance test (IVGTT)
Time Frame
24 weeks
Title
Cognitive function
Description
Evaluated by cognitive testing and functional Magnetic Resonance imaging (MRI)
Time Frame
18 months
Title
Insulin resistance
Description
Evaluated by insulin resistance indexes, HOMA-IR and Matsuda index
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina Majlund Harder-Lauridsen, MD
Organizational Affiliation
Rigshospitalet, 7641
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Signe Tellerup Nielsen, MD
Organizational Affiliation
Rigshospitalet, 7641
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rikke Krogh-Madsen, MD. PhD
Organizational Affiliation
Rigshospitalet, 7641
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bente Klarlund Pedersen, Professor
Organizational Affiliation
Rigshospitalet, 7641
Official's Role
Study Director
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
33512717
Citation
Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
Results Reference
derived

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Bed Rest, Alternate Daily Fasting and Incretin Effect

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