Impacts of Metabolic Variation on Neuroendocrine Control of Reproduction

Study Overview
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Brief Summary
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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.

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

Conditions
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Neuroendocrine Reproductive Status

Intervention / Treatment
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* Dietary Supplement: effect of metabolic variations on LH pulsatility


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: isocaloric<br>impacts of isocaloric nutrition on LH pulsatility in euglycemic and hyperinsulinemic clamps | Dietary Supplement: effect of metabolic variations on LH pulsatility<br>* 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.<br>|
| Other: hypercaloric<br>impacts of hypercaloric nutrition on LH pulsatility in euglycemic and hyperinsulinemic clamps | Dietary Supplement: effect of metabolic variations on LH pulsatility<br>* 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.<br>|
| Other: per os and IV glucose during the clamp<br>impacts of per os glucose on LH pulsatility in euglycemic and hyperinsulinemic clamps | Dietary Supplement: effect of metabolic variations on LH pulsatility<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Luteinizing hormone (LH) pulsatility |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LH pulsatility, GnRH regulation, isocaloric nutrition, hypercaloric nutrition, euglycemic clamps, hyperinsulinemic clamps, testosterone, LH, leptine, ghrelin, PYY, CCK, GLP-1, GIP, cortisol