Effects of Physical Training on Adipose Tissue Metabolism and Insulin Sensitivity in the Menopausal Transition Phase

Not Applicable

Completed

• Conditions: Insulin Resistance; Menopause; Body Composition, Beneficial
• Interventions: Behavioral: Spinning

• Registration Number: NCT02076932
• Lead Sponsor: University of Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-03-03
• Study First Posted: 2014-03-04
• Study Start: 2014-04
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-31
• Last Update Posted: 2016-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

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

• Smoking
• Excessive alcohol intake
• Regular medication including hormone replacement treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Premenopausal women	Spinning	The premenopausal women will be attending Spinning classes.
Postmenopausal Women	Spinning	The postmenopausal women will be attending Spinning classes.

Primary Outcome Measures

Name	Time	Method
Hyperinsulinemic euglycemic clamp	Baseline and 3 months	Glucose metabolized (mg/kg/min)
Adipose tissue distribution	Baseline and 3 months	Accessed by Magnetic Resonance Imaging (MRI).
Insulin stimulated uptake of glucose in adipose tissue	Baseline and 3 months	Measured by Positron Emission Tomography-Computed tomography (PET/CT)

Secondary Outcome Measures

Name	Time	Method
Abdominal subcutaneous adipose tissue biopsy	Baseline and 3 months	Biochemical, proteomics, metabolomics, genomics and morphological analyses
Physical activity level and duration of sleep	Baseline and 3 months	Daily activity and duration of sleep will be recorded during one week using Actibelt® and self reporting
Anthropometry	Baseline and 3 months	Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height
Resting metabolic rate	Baseline and 3 months	Will be measured by indirect calorimetry
Health related quality of life	Baseline and 3 months	Measured using questionaries, semi-structured interviews and observations
Central insulin sensitivity	Baseline and 3 months	Fasting plasma insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test
Skeletal muscle biopsy	Baseline and 3 months	Biochemical, proteomics, metabolomics, genomics and morphological analyses
Femoral subcutaneous adipose tissue biopsy	Baseline and 3 months	Biochemical, proteomics, metabolomics, genomics and morphological analyses
Maximal oxygen uptake (ml/O2/kg/min)	Baseline and 3 months	Measured using indirect calorimetry and an incremental bicycle protocol
Metabolic syndrome	Baseline and 3 months	As measured by high density lipoprotein, triglycerides, waist circumference, blood pressure, mean arterial pressure, fasting glucose and composite metabolic syndrome scores
Microdialysis	Baseline and 3 months	Adipose tissue microdialysis

Trial Locations

Locations (1)

Department og Biomedical Sciences; 🇩🇰 Copenhagen N, Denmark