HealthyFEIGHNCT00817440
Effects of Fasting and Exercise on Insulin and GH Signaltransduction in Muscle and Fat
A study testing Exercise and Fasting in people with Healthy, run by University of Aarhus at 1 site in Denmark.
Trial summary
Hypothesis: under fasting there will primarily be an activation of growth hormone(GH) signalpathways and a inhibition of insulin signalpathways, and the opposite will happen under physical activity. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exercise and Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2008to May 2009
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy men
- Body mass index (BMI) 20-26
- age 18-45 years
Who cannot join
- any kind of disease
- any use of medicine
Trial locations and contacts
1 site in 1 country.
About this study
Hypothesis: under fasting there will primarily be an activation of growth hormone(GH) signalpathways and a inhibition of insulin signalpathways, and the opposite will happen under physical activity.
Primarily we will investigate markers for GH and insulin signaltransduction in muscle- and fat-biopsies after fasting for 72 hours and after 1 hour of ergometer-cycling at 65% Vo2max.
In addition to this we will investigate the effect of fasting and exercise on the velocity of carbamide synthesis, aminoacid rate of turnover and glucose rate of turnover.
- Conditions
- Healthy
- Being tested
- Exercise, Fasting
- Keywords
- growth hormone insulin signaltransduction signalpathways, growth hormone and insulin signalpathways
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
1 hour ergometer cycling on 65% of Vo2max, and then the same as arm 1.
FastingOther
3 days of fasting and then the same as arm 1
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | control: muscle and fat biopsies and basal aminoacid and glucose turnover |
| Exercise | Experimental | 1 hour ergometer cycling on 65% of Vo2max, and then the same as arm 1. Receives: Other: Exercise |
| Fasting | Experimental | 3 days of fasting and then the same as arm 1 Receives: Other: Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth hormone and insulin signal pathways
Measured: 30 min
Secondary outcomes (1)
aminoacid and glucose turnover
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817440
- Sponsor's protocol ID
- 16.12.2008
- Acronym
- FEIGH
- Status last verified
- Jan 2011
- First submitted
- 5 Jan 2009
- Last updated
- 11 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fasting and Exercise on Insulin and GH Signaltransduction in Muscle and Fat
- ClinicalTrials.gov ID
- NCT00817440
- Acronym / sponsor ID
- FEIGH / 16.12.2008
- Conditions
- Healthy
- Keywords
- growth hormone insulin signaltransduction signalpathways, growth hormone and insulin signalpathways
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- May 2009 (actual)
- First posted
- 6 Jan 2009 (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.
Hypothesis: under fasting there will primarily be an activation of growth hormone(GH) signalpathways and a inhibition of insulin signalpathways, and the opposite will happen under physical activity.
Primarily we will investigate markers for GH and insulin signaltransduction in muscle- and fat-biopsies after fasting for 72 hours and after 1 hour of ergometer-cycling at 65% Vo2max.
In addition to this we will investigate the effect of fasting and exercise on the velocity of carbamide synthesis, aminoacid rate of turnover and glucose rate of turnover.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –control: muscle and fat biopsies and basal aminoacid and glucose turnover |
| Exercise | Experimental | Other: Exercise1 hour ergometer cycling on 65% of Vo2max, and then the same as arm 1. |
| Fasting | Experimental | Other: Fasting3 days of fasting and then the same as arm 1 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy men
- Body mass index (BMI) 20-26
- age 18-45 years
Key exclusion criteria (2 listed)
- any kind of disease
- any use of medicine
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 |
|---|---|---|
| Exercise1 hour ergometer cycling on 65% of Vo2max, and then the same as arm 1. | Other | Exercise |
| Fasting3 days of fasting and then the same as arm 1 | Other | Fasting |
Primary outcome
Growth hormone and insulin signal pathways
Time frame: 30 min
1 secondary outcome
aminoacid and glucose turnover
Time frame: 4 hours
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 11 Jan 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Fasting in people with Healthy, run by University of Aarhus 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 3 inclusion and 2 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 11 Jan 2011. 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?
Growth hormone and insulin signal pathways (time frame: 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2011.