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Impacts of Metabolic Variation on Neuroendocrine Control of Reproduction

V

Vaud University Hospital Center

Status

Completed

Conditions

Neuroendocrine Reproductive Status

Treatments

Dietary Supplement: effect of metabolic variations on LH pulsatility

Study type

Interventional

Funder types

Other

Identifiers

NCT01058681
Swiss national science fund
Grant number 320030-124886 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

Male

Ages

18 to 25 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

9 participants in 3 patient groups

isocaloric
Other group
Description:
impacts of isocaloric nutrition on LH pulsatility in euglycemic and hyperinsulinemic clamps
Treatment:
Dietary Supplement: effect of metabolic variations on LH pulsatility
hypercaloric
Other group
Description:
impacts of hypercaloric nutrition on LH pulsatility in euglycemic and hyperinsulinemic clamps
Treatment:
Dietary Supplement: effect of metabolic variations on LH pulsatility
per os and IV glucose during the clamp
Other group
Description:
impacts of per os glucose on LH pulsatility in euglycemic and hyperinsulinemic clamps
Treatment:
Dietary Supplement: effect of metabolic variations on LH pulsatility

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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