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Effects of Gynecological Age on LH Sensitivity to Energy Availability

This study has been completed.
Sponsor:
Collaborator:
Ohio State University
Information provided by:
Ohio University
ClinicalTrials.gov Identifier:
NCT00260286
First received: November 30, 2005
Last updated: December 2, 2005
Last verified: November 2005
  Purpose

The purpose of this experiment is to investigate whether the dependence of luteinizing hormone pulsatility on energy availability declines during adolescence.


Condition Intervention
Anovulation
Amenorrhea
Infertility
Starvation
Behavioral: Energy availability

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Dietary Energy Requirements in Physically Active Men and Women, Objective 4B: Effects of Gynecological Age on LH Sensitivity to Energy Availability

Resource links provided by NLM:


Further study details as provided by Ohio University:

Primary Outcome Measures:
  • Differences in 24h LH pulse frequency, 24h LH pulse amplitude and 24h LH mean concentration in blood samples drawn q10' for 24 hours after 5 days of treatment

Secondary Outcome Measures:
  • Differences in 24h average glucose, beta-hydroxybutyrate, insulin, cortisol, growth hormone, insulin-like growth factor-I, tri-iodothyronine, and leptin concentrations in blood samples drawn q10' for 24 hours after 5 days of treatment

Estimated Enrollment: 18
Study Start Date: August 2001
Estimated Study Completion Date: May 2004
Detailed Description:

The incidence of menstrual disorders declines during adolescence. This has long been attributed to the gradual "maturation" of the hypothalamic-pituitary-ovarian axis, but the mechanism of this "maturation" is not known. Ovarian function critically depends on the pulsatile secretion of gonadotropin-releasing hormone (GnRH) by the hypothalamus and on the consequent and more readily assessed pulsatility of luteinizing hormone (LH) secretion by the pituitary. LH pulsatility has been shown to depend on energy availability, operationally defined as dietary energy intake minus exercise energy expenditure. The effects of energy availability on LH pulsatility are thought to be mediated by certain metabolic substrates and hormones.

Comparison: By manipulating diet and exercise regimens, contrasting energy availability treatments of 10 and 45 kilocalories per kilogram of fat-free mass per day are being administered to adolescents with 5-8 years of gynecological age and to adults with 14-18 years of gynecological age for five days in the early follicular phase of separate menstrual cycles. Effects of low energy availability on LH pulsatility and on selected metabolic substrates and hormones are being measured.

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 5-8 or 14-18 years of gynecological age
  • menstrual cycles of 26 to 32 days for the previous 3 months
  • luteal phase length >11 days
  • 18-32% body fat

Exclusion Criteria:

  • smoking
  • oral contraceptives
  • hematocrit <35%
  • diet with <35 or >55 kcal/kgFFM/day of energy
  • habitually performing more than 60 minutes/week of aerobic exercise
  • histories or evidence of heart, liver, or kidney disease, diabetes, menstrual or thyroid disorders, pregnancy, lactation, and congenital or acquired orthopedic abnormalities
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00260286

Locations
United States, Ohio
Ohio University
Athens, Ohio, United States, 45701
Sponsors and Collaborators
Ohio University
Ohio State University
Investigators
Principal Investigator: Anne B Loucks, Ph.D. Ohio University
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00260286     History of Changes
Other Study ID Numbers: Excalibur X, DAMD_17-95-1-5053,, M01_RR00034
Study First Received: November 30, 2005
Last Updated: December 2, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio University:
LH pulsatility
energy availability
exercise
diet
gynecological age

Additional relevant MeSH terms:
Amenorrhea
Anovulation
Infertility
Starvation
Adnexal Diseases
Endocrine System Diseases
Genital Diseases, Female
Genital Diseases, Male
Gonadal Disorders
Malnutrition
Menstruation Disturbances
Nutrition Disorders
Ovarian Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014