Menopausal Sleep Fragmentation and Body Fat Gain

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study aims to investigate the impact of menopause-related sleep fragmentation on metabolic biomarkers of body fat gain. The investigators hypothesize that experimental sleep fragmentation will result in an adverse leptin response as a metabolic biomarker for body fat gain.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: National Institute on Aging (NIA)
• Treatments: Leuprolide

Criteria

Inclusion Criteria:

• Healthy premenopausal women 18-45 years old

• Regular sleep schedule

• Limited alcohol and caffeine intake

• Regular monthly menstrual cycles

• No lifetime history of hot flashes

• Willingness to use approved methods of contraception during study

• Not obese

• Good general health

Exclusion Criteria:

• Contraindication, hypersensitivity or previous adverse reaction to gonadotropin releasing hormone agonists

• Pregnancy

• Breastfeeding

• Tobacco use

• Contraindicated systemic hormone medications or centrally active medications

• Shift workers or recent/expected time zone travel

• Obstructive sleep apnea

• Insomnia symptoms

• Diagnosis of osteoporosis or osteopenia

• Hypothalamic-pituitary-adrenal axis disorders

• Diabetes

• Gastric bypass, metabolic disorders, or other related conditions

• Abnormalities on screening laboratory tests

• Substantial hearing impairment

• Cardiovascular illness

• Neurological illness

• Recent psychiatric illness or substance-use disorder