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Impacts of Metabolic Variation on Neuroendocrine Control of Reproduction

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ClinicalTrials.gov Identifier: NCT01058681
Recruitment Status : Completed
First Posted : January 29, 2010
Last Update Posted : August 3, 2011
Sponsor:
Information provided by:
Centre Hospitalier Universitaire Vaudois

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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Reproductive Status Dietary Supplement: effect of metabolic variations on LH pulsatility Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impacts of Metabolic Variation on the Activity of Neuroendocrine Reproductive Axis in Healthy Volunteers
Study Start Date : January 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
isocaloric
impacts of isocaloric nutrition on LH pulsatility in euglycemic and hyperinsulinemic clamps
Dietary Supplement: 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.


hypercaloric
impacts of hypercaloric nutrition on LH pulsatility in euglycemic and hyperinsulinemic clamps
Dietary Supplement: 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.


per os and IV glucose during the clamp
impacts of per os glucose on LH pulsatility in euglycemic and hyperinsulinemic clamps
Dietary Supplement: 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.





Primary Outcome Measures :
  1. Luteinizing hormone (LH) pulsatility [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058681


Locations
Switzerland
CHUVaudois
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
Principal Investigator: François Pralong CHUV
Study Director: Vittorio Giusti CHUV
Study Director: Luc Tappy CHUV
Study Director: Marie-Hélène Pesant CHUV

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. François Pralong, CHUV
ClinicalTrials.gov Identifier: NCT01058681     History of Changes
Other Study ID Numbers: Swiss national science fund
Grant number 320030-124886 ( Other Grant/Funding Number: Swiss national science fund )
First Posted: January 29, 2010    Key Record Dates
Last Update Posted: August 3, 2011
Last Verified: October 2010

Keywords provided by Centre Hospitalier Universitaire Vaudois:
LH pulsatility
GnRH regulation
isocaloric nutrition
hypercaloric nutrition
euglycemic clamps
hyperinsulinemic clamps
testosterone
LH
leptine
ghrelin
PYY
CCK
GLP-1
GIP
cortisol