Impacts of Metabolic Variation on Neuroendocrine Control of Reproduction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-10-31

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.

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Detailed Description

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Conditions

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Neuroendocrine Reproductive Status

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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isocaloric

impacts of isocaloric nutrition on LH pulsatility in euglycemic and hyperinsulinemic clamps

Group Type OTHER

effect of metabolic variations on LH pulsatility

Intervention Type DIETARY_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.

hypercaloric

impacts of hypercaloric nutrition on LH pulsatility in euglycemic and hyperinsulinemic clamps

Group Type OTHER

effect of metabolic variations on LH pulsatility

Intervention Type DIETARY_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.

per os and IV glucose during the clamp

impacts of per os glucose on LH pulsatility in euglycemic and hyperinsulinemic clamps

Group Type OTHER

effect of metabolic variations on LH pulsatility

Intervention Type DIETARY_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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes