Metabolic SyndromeNCT02134860
Bed Rest, Alternate Daily Fasting and Incretin Effect
A study testing Bed rest, OGTT and IVGTT in people with Metabolic Syndrome and Type 2 Diabetes, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Type 2 Diabetes, Critical Illness
- What is being tested?
- Bed rest, OGTT and IVGTT
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI<25kg/m2
- VO2 max normal for age
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study on the Incretin Effect, Cognitive Function and Controlled Fasting During Bed Rest in Healthy Male Volunteers
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).
Read more
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
Read the 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.
- Conditions
- Metabolic Syndrome, Type 2 Diabetes, Critical Illness
- Being tested
- Bed rest, OGTT, IVGTT, Cognitive testing, Muscle and fat biopsies
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Type 2, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bed restOther
8 days of full bed rest
OGTTOther
Oral glucose tolerance test with 75 g of glucose before and after bed rest
IVGTTOther
Intravenous glucose tolerance test mimicking the glucose profile from the corresponding OGTT
Cognitive testingOther
Daily testing of memory and concentration using standardized tests
Muscle and fat biopsiesOther
Biopsies will be obtained before and after bed rest
Dual-energy X-ray Absorptiometry (DXA) scanOther
DXA scan to evaluate fat and muscle distribution before and after bed rest
MRIOther
Functional MRI to evaluate cognitive function and abdominal MRI to evaluate visceral fat before and after bed rest
| Study group | Role | What they receive |
|---|---|---|
| Isocaloric diet | Active comparator | 3 daily meals Receives: 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 |
| Alternate daily fasting | Active comparator | One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incretin effect
Measured by Insulin levels during Oral glucose tolerance test (OGTT) and Intravenous glucose tolerance test (IVGTT)
Measured: 24 weeks
Cognitive function
Evaluated by cognitive testing and functional Magnetic Resonance imaging (MRI)
Measured: 18 months
Insulin resistance
Evaluated by insulin resistance indexes, HOMA-IR and Matsuda index
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Rasmussen Rinnov, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Nina Majlund Harder-Lauridsen, MD, Principal investigator, Rigshospitalet, 7641Signe Tellerup Nielsen, MD, Principal investigator, Rigshospitalet, 7641Rikke Krogh-Madsen, MD. PhD, Principal investigator, Rigshospitalet, 7641Bente Klarlund Pedersen, Professor, Study director, Rigshospitalet, 7641
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134860
- Sponsor's protocol ID
- H-6-2014-017
- Status last verified
- Sep 2014
- First submitted
- 29 Apr 2014
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33512717
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Incretin Effect, Cognitive Function and Controlled Fasting During Bed Rest in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02134860
- Acronym / sponsor ID
- H-6-2014-017
- Conditions
- Metabolic Syndrome, Type 2 Diabetes, Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isocaloric diet | Active comparator | Other: Bed rest, Other: OGTT, Other: IVGTT, Other: Cognitive testing, Other: Muscle and fat biopsies, Other: Dual-energy X-ray Absorptiometry (DXA) scan, Other: MRI3 daily meals |
| Alternate daily fasting | Active comparator | Other: Bed rest, Other: OGTT, Other: IVGTT, Other: Cognitive testing, Other: Muscle and fat biopsies, Other: Dual-energy X-ray Absorptiometry (DXA) scan, Other: MRIOne meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI<25kg/m2
- VO2 max normal for age
Key exclusion criteria (7 listed)
- Tobacco smoking
- Alcohol ingestion > 14 units per week
- Diabetes in nearby relatives
- Resection of the small intestine
- History of gastric bypass surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bed rest8 days of full bed rest | Other | Alternate daily fasting, Isocaloric diet |
| OGTTOral glucose tolerance test with 75 g of glucose before and after bed rest | Other | Alternate daily fasting, Isocaloric diet |
| IVGTTIntravenous glucose tolerance test mimicking the glucose profile from the corresponding OGTT | Other | Alternate daily fasting, Isocaloric diet |
| Cognitive testingDaily testing of memory and concentration using standardized tests | Other | Alternate daily fasting, Isocaloric diet |
| Muscle and fat biopsiesBiopsies will be obtained before and after bed rest | Other | Alternate daily fasting, Isocaloric diet |
| Dual-energy X-ray Absorptiometry (DXA) scanDXA scan to evaluate fat and muscle distribution before and after bed rest | Other | Alternate daily fasting, Isocaloric diet |
| MRIFunctional MRI to evaluate cognitive function and abdominal MRI to evaluate visceral fat before and after bed rest | Other | Alternate daily fasting, Isocaloric diet |
Primary outcome
Incretin effect
Time frame: 24 weeks
Measured by Insulin levels during Oral glucose tolerance test (OGTT) and Intravenous glucose tolerance test (IVGTT)
Cognitive function
Time frame: 18 months
Evaluated by cognitive testing and functional Magnetic Resonance imaging (MRI)
Insulin resistance
Time frame: 12 weeks
Evaluated by insulin resistance indexes, HOMA-IR and Matsuda index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2014.
- Derived from this study: PubMed 33512717Allaf 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Majlund Harder-Lauridsen, MD principal investigator
Rigshospitalet, 7641
Signe Tellerup Nielsen, MD principal investigator
Rigshospitalet, 7641
Rikke Krogh-Madsen, MD. PhD principal investigator
Rigshospitalet, 7641
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bed rest, OGTT and IVGTT in people with Metabolic Syndrome and Type 2 Diabetes, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incretin effect (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02134860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2014.