Text Size

Impacts of Metabolic Variation on Neuroendocrine Control of Reproduction

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT01058681
First received: January 28, 2010
Last updated: August 2, 2011
Last verified: October 2010
History of Changes
  Purpose

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 Intervention
Neuroendocrine Reproductive Status
 Dietary Supplement: effect of metabolic variations on LH pulsatility

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Impacts of Metabolic Variation on the Activity of Neuroendocrine Reproductive Axis in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • Luteinizing hormone (LH) pulsatility [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: January 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Centre Hospitalier Universitaire Vaudois

Additional 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
Study First Received: January 28, 2010
Last Updated: August 2, 2011
Health Authority: Switzerland: Federal Office of Public Health

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

ClinicalTrials.gov processed this record on May 22, 2013