Skip to main content
Clinical Trials/NCT02076932
NCT02076932
Completed
N/A

A Training Intervention Study in Late Pre- and Early Postmenopausal Women Investigating the Changes in Adipose Tissue Metabolism and Peripheral Insulin Sensitivity

University of Copenhagen1 site in 1 country43 target enrollmentApril 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Menopause
Sponsor
University of Copenhagen
Enrollment
43
Locations
1
Primary Endpoint
Hyperinsulinemic euglycemic clamp
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this study is to determine if physical exercise reduces the adverse changes in adipose tissue metabolism and insulin sensitivity that occurs in women during the menopausal transition.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
January 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bente Merete Stallknecht

Professor, MD

University of Copenhagen

Eligibility Criteria

Inclusion Criteria

  • Premenopausal OR Postmenopausal (45-57 years)
  • No chronical Diseases
  • BMI \> 18,5 and \< 30
  • Sedentary (no regular physical activity the last 2 years)
  • Either regular bleeding (premenopausal) OR no menstruation for at least 2 years (postmenopausal)
  • Plasma measurements:
  • Premenopausal: estradiol \> 0.20nmol/l, Follicle Stimulating Hormone \< 22 IU/l and progesterone \> 2.5 nmol/l Postmenopausal: estradiol \< 0.20nmol/l, Follicle Stimulating Hormone \> 22 IU/l and progesterone from 0.3-2.5 nmol/l

Exclusion Criteria

  • Excessive alcohol intake
  • Regular medication including hormone replacement treatment

Outcomes

Primary Outcomes

Hyperinsulinemic euglycemic clamp

Time Frame: Baseline and 3 months

Glucose metabolized (mg/kg/min)

Adipose tissue distribution

Time Frame: Baseline and 3 months

Accessed by Magnetic Resonance Imaging (MRI).

Insulin stimulated uptake of glucose in adipose tissue

Time Frame: Baseline and 3 months

Measured by Positron Emission Tomography-Computed tomography (PET/CT)

Secondary Outcomes

  • Abdominal subcutaneous adipose tissue biopsy(Baseline and 3 months)
  • Physical activity level and duration of sleep(Baseline and 3 months)
  • Anthropometry(Baseline and 3 months)
  • Resting metabolic rate(Baseline and 3 months)
  • Health related quality of life(Baseline and 3 months)
  • Central insulin sensitivity(Baseline and 3 months)
  • Skeletal muscle biopsy(Baseline and 3 months)
  • Femoral subcutaneous adipose tissue biopsy(Baseline and 3 months)
  • Maximal oxygen uptake (ml/O2/kg/min)(Baseline and 3 months)
  • Metabolic syndrome(Baseline and 3 months)
  • Microdialysis(Baseline and 3 months)

Study Sites (1)

Loading locations...

Similar Trials