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Impacts of Metabolic Variation on Neuroendocrine Control of Reproduction

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01058681
Enrollment
9
Registered
2010-01-29
Start date
2010-01-31
Completion date
2010-10-31
Last updated
2011-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Reproductive Status

Keywords

LH pulsatility, GnRH regulation, isocaloric nutrition, hypercaloric nutrition, euglycemic clamps, hyperinsulinemic clamps, testosterone, LH, leptine, ghrelin, PYY, CCK, GLP-1, GIP, cortisol

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.

Interventions

DIETARY_SUPPLEMENTeffect 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.

Sponsors

Centre Hospitalier Universitaire Vaudois
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 25 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
Luteinizing hormone (LH) pulsatility2 years

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026