Impacts of Metabolic Variation on Neuroendocrine Control of Reproduction

Not Applicable

Completed

• Conditions: Neuroendocrine Reproductive Status
• Interventions: Dietary Supplement: effect of metabolic variations on LH pulsatility

• Registration Number: NCT01058681
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-28
• Study First Submitted QC: 2010-01-28
• Study First Posted: 2010-01-29
• Status Verified: 2010-10
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Last Update Submitted: 2011-08-02
• Last Update Posted: 2011-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
isocaloric	effect of metabolic variations on LH pulsatility	impacts of isocaloric nutrition on LH pulsatility in euglycemic and hyperinsulinemic clamps
hypercaloric	effect of metabolic variations on LH pulsatility	impacts of hypercaloric nutrition on LH pulsatility in euglycemic and hyperinsulinemic clamps
per os and IV glucose during the clamp	effect of metabolic variations on LH pulsatility	impacts of per os glucose on LH pulsatility in euglycemic and hyperinsulinemic clamps

Primary Outcome Measures

Name	Time	Method
Luteinizing hormone (LH) pulsatility	2 years

Trial Locations

Locations (1)

CHUVaudois; 🇨🇭 Lausanne, Switzerland