NCT00260286

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2001

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
Last Updated

December 5, 2005

Status Verified

November 1, 2005

First QC Date

November 30, 2005

Last Update Submit

December 2, 2005

Conditions

AnovulationAmenorrheaInfertilityStarvation

Keywords

LH pulsatilityenergy availabilityexercisedietgynecological age

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Interventions

Energy availabilityBEHAVIORAL

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

Related Publications (8)

  • 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.

    PMID: 9451615BACKGROUND

  • 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.

    PMID: 8160876BACKGROUND

  • 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.

    PMID: 10644535BACKGROUND

  • 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.

    PMID: 8498602BACKGROUND

  • 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.

    PMID: 8157720BACKGROUND

  • 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.

    PMID: 9756553BACKGROUND

  • 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.

    PMID: 12519869BACKGROUND

  • 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.

    PMID: 15231009BACKGROUND

MeSH Terms

Conditions

AnovulationAmenorrheaInfertilityStarvationMotor Activity

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesMenstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsMalnutritionNutrition DisordersNutritional and Metabolic DiseasesBehavior

Study Officials

  • Anne B Loucks, Ph.D.

    Ohio University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2005

First Posted

December 1, 2005

Study Start

August 1, 2001

Study Completion

May 1, 2004

Last Updated

December 5, 2005

Record last verified: 2005-11

Locations

US(1)