Completed

NCT Number: NCT01058681

Impacts of Metabolic Variation on Neuroendocrine Control of Reproduction

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.

Completed

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Key information

Conditions

Neuroendocrine Reproductive Status

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CHUVaudois

Lausanne, 1011, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

effect of metabolic variations on LH pulsatility

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.

Primary outcomes

Luteinizing hormone (LH) pulsatility

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Jan 29, 2010
Registry last updated: Aug 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.