Neuroendocrine Reproductive StatusNCT01058681
Impacts of Metabolic Variation on Neuroendocrine Control of Reproduction
A study testing effect of metabolic variations on LH pulsatility in people with Neuroendocrine Reproductive Status, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
This study will evaluate the potential effects of a changing metabolic environment on GnRH hypothalamic neurons, by performing studies of LH pulsatility (basal and during clamp studies) in different groups of male subjects fed isocaloric and hypercaloric diets. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neuroendocrine Reproductive Status
- What is being tested?
- effect of metabolic variations on LH pulsatility
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Oct 2010
- 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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- age between 18 and 25 years old
- no known pathology
- normal physical exam
- BMI between 20 and 25 kg/m2
Who cannot join
- history of endocrine disease
- no known infertility (no conception after 12 months of regular unprotected intercourse)
- abnormal results on the initial blood tests (CBC, fasting glucose and insulin, HbA1C, TSH, free T4, LH, FSH, inhibin B and total testosterone)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impacts of Metabolic Variation on the Activity of Neuroendocrine Reproductive Axis in Healthy Volunteers
This study will evaluate the potential effects of a changing metabolic environment on GnRH hypothalamic neurons, by performing studies of LH pulsatility (basal and during clamp studies) in different groups of male subjects fed isocaloric and hypercaloric diets. The participation of other gastro-intestinal tract hormones to these regulations will be systematically evaluated.
- Conditions
- Neuroendocrine Reproductive Status
- Being tested
- effect of metabolic variations on LH pulsatility
- Keywords
- LH pulsatility, GnRH regulation, isocaloric nutrition, hypercaloric nutrition, euglycemic clamps, hyperinsulinemic clamps, testosterone, LH, leptine, ghrelin, PYY, CCK, GLP-1, GIP, cortisol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
effect of metabolic variations on LH pulsatilityDietary supplement
Isocaloric diet: 1,5 times basal metabolism. Constitution:55% carbohydrates, 15% proteins and 30% fat.
Hypercaloric diet: addition of 30% fat and 3 g of fructose/kg of weight to isocaloric diet.
PO and IV glucose during clamps: PO administration of 90 mg/kg glucose at 90 minutes intervals during the clamp, and adjustment of the IV perfusion to keep euglycemia.
| Study group | Role | What they receive |
|---|---|---|
| isocaloric | Other | impacts of isocaloric nutrition on LH pulsatility in euglycemic and hyperinsulinemic clamps Receives: Dietary Supplement: effect of metabolic variations on LH pulsatility |
| hypercaloric | Other | impacts of hypercaloric nutrition on LH pulsatility in euglycemic and hyperinsulinemic clamps Receives: Dietary Supplement: effect of metabolic variations on LH pulsatility |
| per os and IV glucose during the clamp | Other | impacts of per os glucose on LH pulsatility in euglycemic and hyperinsulinemic clamps Receives: Dietary Supplement: effect of metabolic variations on LH pulsatility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Luteinizing hormone (LH) pulsatility
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionOct 2010
- Study completionOct 2010
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 Neuroendocrine Reproductive StatusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Investigators
- François Pralong, Principal investigator, CHUVVittorio Giusti, Study director, CHUVLuc Tappy, Study director, CHUVMarie-Hélène Pesant, Study director, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058681
- Sponsor's protocol ID
- Swiss national science fund
- Other IDs
- Grant number 320030-124886
- Status last verified
- Oct 2010
- First submitted
- 28 Jan 2010
- Last updated
- 3 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Pesant MH, Dwyer A, Marques Vidal P, Schneiter P, Giusti V, Tappy L, Pralong FP. The lack of effect of insulin on luteinizing hormone pulsatility in healthy male volunteers provides evidence of a sexual dimorphism in the metabolic regulation of reproductive hormones. Am J Clin Nutr. 2012 Aug;96(2):283-8. doi: 10.3945/ajcn.111.030189. Epub 2012 Jul 3.
PubMed 22760567
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of Metabolic Variation on the Activity of Neuroendocrine Reproductive Axis in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01058681
- Acronym / sponsor ID
- Swiss national science fund
- Conditions
- Neuroendocrine Reproductive Status
- Keywords
- LH pulsatility, GnRH regulation, isocaloric nutrition, hypercaloric nutrition, euglycemic clamps, hyperinsulinemic clamps, testosterone, LH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 29 Jan 2010 (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.
This study will evaluate the potential effects of a changing metabolic environment on GnRH hypothalamic neurons, by performing studies of LH pulsatility (basal and during clamp studies) in different groups of male subjects fed isocaloric and hypercaloric diets. The participation of other gastro-intestinal tract hormones to these regulations will be systematically evaluated.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| isocaloric | Other | Dietary Supplement: effect of metabolic variations on LH pulsatilityimpacts of isocaloric nutrition on LH pulsatility in euglycemic and hyperinsulinemic clamps |
| hypercaloric | Other | Dietary Supplement: effect of metabolic variations on LH pulsatilityimpacts of hypercaloric nutrition on LH pulsatility in euglycemic and hyperinsulinemic clamps |
| per os and IV glucose during the clamp | Other | Dietary Supplement: effect of metabolic variations on LH pulsatilityimpacts of per os glucose on LH pulsatility in euglycemic and hyperinsulinemic clamps |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- male
- age between 18 and 25 years old
- no known pathology
- normal physical exam
- BMI between 20 and 25 kg/m2
Key exclusion criteria (3 listed)
- history of endocrine disease
- no known infertility (no conception after 12 months of regular unprotected intercourse)
- abnormal results on the initial blood tests (CBC, fasting glucose and insulin, HbA1C, TSH, free T4, LH, FSH, inhibin B and total testosterone)
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 |
|---|---|---|
| effect of metabolic variations on LH pulsatilityIsocaloric diet: 1,5 times basal metabolism. Constitution:55% carbohydrates, 15% proteins and 30% fat. Hypercaloric diet: addition of 30% fat and 3 g of fructose/kg of weight to isocaloric diet. PO and IV glucose during clamps: PO administration of 90 mg/kg glucose at 90 minutes intervals during the clamp, and adjustment of the IV perfusion to keep euglycemia. | Dietary supplement | hypercaloric, isocaloric, per os and IV glucose during the clamp |
Primary outcome
Luteinizing hormone (LH) pulsatility
Time frame: 2 years
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 3 Aug 2011.
- Derived from this study: PubMed 22760567Pesant MH, Dwyer A, Marques Vidal P, Schneiter P, Giusti V, Tappy L, Pralong FP. The lack of effect of insulin on luteinizing hormone pulsatility in healthy male volunteers provides evidence of a sexual dimorphism in the metabolic regulation of reproductive hormones. Am J Clin Nutr. 2012 Aug;96(2):283-8. doi: 10.3945/ajcn.111.030189. Epub 2012 Jul 3.
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.
François Pralong principal investigator
CHUV
Vittorio Giusti study director
CHUV
Luc Tappy study director
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing effect of metabolic variations on LH pulsatility in people with Neuroendocrine Reproductive Status, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 5 inclusion and 3 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 3 Aug 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 Switzerland. 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?
Luteinizing hormone (LH) pulsatility (time frame: 2 years). 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 NCT01058681, 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 3 Aug 2011; AzTrials last refreshed its copy on 8 Nov 2026.