Impacts of Metabolic Variation on Neuroendocrine Control of Reproduction

Neuroendocrine Reproductive Status Clinical Trial

Official title:

Impacts of Metabolic Variation on the Activity of Neuroendocrine Reproductive Axis in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058681
• Other study ID #: Swiss national science fund
• Secondary ID: Grant number 320
• Status: Completed
• Phase: N/A
• First received: January 28, 2010
• Last updated: August 2, 2011
• Start date: January 2010
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical 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. The participation of other gastro-intestinal tract hormones to these regulations will be systematically evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• male

• age between 18 and 25 years old

• no known pathology

• normal physical exam

• BMI between 20 and 25 kg/m2

Exclusion Criteria:

• 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)

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Neuroendocrine Reproductive Status

Intervention

Dietary Supplement:
• effect of metabolic variations on LH pulsatility
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.

Locations

Country	Name	City	State
Switzerland	CHUVaudois	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Luteinizing hormone (LH) pulsatility		2 years	No