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

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

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance; Menopause; Body Composition, Beneficial
• Intervention / Treatment: Behavioral: Spinning

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen N, Denmark, 2200
    • Department og Biomedical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 57 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Premenopausal women; The premenopausal women will be attending Spinning classes.	Behavioral: Spinning; After the baseline studies, the women will perform Spinning three times a week. Two of the sessions are performed on our location by trained instructors and the third training is self-training in a local fitness center where we provide free membership. All trainings are heart rate monitored.
Experimental: Postmenopausal Women; The postmenopausal women will be attending Spinning classes.	Behavioral: Spinning; After the baseline studies, the women will perform Spinning three times a week. Two of the sessions are performed on our location by trained instructors and the third training is self-training in a local fitness center where we provide free membership. All trainings are heart rate monitored.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary registration	Daily food intake for three week days and one week-end day will be reported by the subjects	Baseline and 3 months

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Rigshospitalet, Denmark; Glostrup University Hospital, Copenhagen
• Investigators: Principal Investigator: Ylva Hellsten, Proff., University of Copenhagen; Principal Investigator: Bente M Stallknecht, Proff. MD, University of Copenhagen

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: March 3, 2014
• First Posted (Estimate): March 4, 2014

Study Record Updates

• Last Update Posted (Estimate): June 1, 2016
• Last Update Submitted That Met QC Criteria: May 31, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: CWS menopause, adipose tissue