Effects of Gynecological Age on LH Sensitivity to Energy Availability
Primary Purpose
Anovulation, Amenorrhea, Infertility
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Energy availability
Sponsored by
About this trial
This is an interventional prevention trial for Anovulation focused on measuring LH pulsatility, energy availability, exercise, diet, gynecological age
Eligibility 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
Sites / Locations
- Ohio University
Outcomes
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
Full Information
NCT ID
NCT00260286
First Posted
November 30, 2005
Last Updated
December 2, 2005
Sponsor
Ohio University
Collaborators
Ohio State University
1. Study Identification
Unique Protocol Identification Number
NCT00260286
Brief Title
Effects of Gynecological Age on LH Sensitivity to Energy Availability
Official Title
Dietary Energy Requirements in Physically Active Men and Women, Objective 4B: Effects of Gynecological Age on LH Sensitivity to Energy Availability
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Ohio University
Collaborators
Ohio State University
4. Oversight
5. Study Description
Brief Summary
The purpose of this experiment is to investigate whether the dependence of luteinizing hormone pulsatility on energy availability declines during adolescence.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anovulation, Amenorrhea, Infertility, Starvation
Keywords
LH pulsatility, energy availability, exercise, diet, gynecological age
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Energy availability
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne B Loucks, Ph.D.
Organizational Affiliation
Ohio University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio University
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9451615
Citation
Loucks AB, Verdun M, Heath EM. Low energy availability, not stress of exercise, alters LH pulsatility in exercising women. J Appl Physiol (1985). 1998 Jan;84(1):37-46. doi: 10.1152/jappl.1998.84.1.37.
Results Reference
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PubMed Identifier
8160876
Citation
Loucks AB, Heath EM. Induction of low-T3 syndrome in exercising women occurs at a threshold of energy availability. Am J Physiol. 1994 Mar;266(3 Pt 2):R817-23. doi: 10.1152/ajpregu.1994.266.3.R817.
Results Reference
background
PubMed Identifier
10644535
Citation
Hilton LK, Loucks AB. Low energy availability, not exercise stress, suppresses the diurnal rhythm of leptin in healthy young women. Am J Physiol Endocrinol Metab. 2000 Jan;278(1):E43-9. doi: 10.1152/ajpendo.2000.278.1.E43.
Results Reference
background
PubMed Identifier
8498602
Citation
Loucks AB, Callister R. Induction and prevention of low-T3 syndrome in exercising women. Am J Physiol. 1993 May;264(5 Pt 2):R924-30. doi: 10.1152/ajpregu.1993.264.5.R924.
Results Reference
background
PubMed Identifier
8157720
Citation
Loucks AB, Heath EM. Dietary restriction reduces luteinizing hormone (LH) pulse frequency during waking hours and increases LH pulse amplitude during sleep in young menstruating women. J Clin Endocrinol Metab. 1994 Apr;78(4):910-5. doi: 10.1210/jcem.78.4.8157720.
Results Reference
background
PubMed Identifier
9756553
Citation
Loucks AB, Verdun M. Slow restoration of LH pulsatility by refeeding in energetically disrupted women. Am J Physiol. 1998 Oct;275(4):R1218-26. doi: 10.1152/ajpregu.1998.275.4.R1218.
Results Reference
background
PubMed Identifier
12519869
Citation
Loucks AB, Thuma JR. Luteinizing hormone pulsatility is disrupted at a threshold of energy availability in regularly menstruating women. J Clin Endocrinol Metab. 2003 Jan;88(1):297-311. doi: 10.1210/jc.2002-020369.
Results Reference
background
PubMed Identifier
15231009
Citation
Ihle R, Loucks AB. Dose-response relationships between energy availability and bone turnover in young exercising women. J Bone Miner Res. 2004 Aug;19(8):1231-40. doi: 10.1359/JBMR.040410. Epub 2004 Apr 19.
Results Reference
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Effects of Gynecological Age on LH Sensitivity to Energy Availability
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