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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076932
• Other study ID #: CWS menopause, adipose tissue
• Status: Completed
• Phase: N/A
• First received: February 24, 2014
• Last updated: May 31, 2016
• Start date: April 2014
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 57 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Body Composition, Beneficial
• Insulin Resistance
• Menopause
• Metabolism, Inborn Errors

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department og Biomedical Sciences	Copenhagen N

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Glostrup University Hospital, Copenhagen, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dietary registration	Daily food intake for three week days and one week-end day will be reported by the subjects	Baseline and 3 months	No
Primary	Insulin stimulated uptake of glucose in adipose tissue	Measured by Positron Emission Tomography-Computed tomography (PET/CT)	Baseline and 3 months	No
Primary	Hyperinsulinemic euglycemic clamp	Glucose metabolized (mg/kg/min)	Baseline and 3 months	No
Primary	Adipose tissue distribution	Accessed by Magnetic Resonance Imaging (MRI).	Baseline and 3 months	No
Secondary	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	No
Secondary	Maximal oxygen uptake (ml/O2/kg/min)	Measured using indirect calorimetry and an incremental bicycle protocol	Baseline and 3 months	No
Secondary	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	No
Secondary	Health related quality of life	Measured using questionaries, semi-structured interviews and observations	Baseline and 3 months	No
Secondary	Anthropometry	Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height	Baseline and 3 months	No
Secondary	Skeletal muscle biopsy	Biochemical, proteomics, metabolomics, genomics and morphological analyses	Baseline and 3 months	No
Secondary	Abdominal subcutaneous adipose tissue biopsy	Biochemical, proteomics, metabolomics, genomics and morphological analyses	Baseline and 3 months	No
Secondary	Resting metabolic rate	Will be measured by indirect calorimetry	Baseline and 3 months	No
Secondary	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	No
Secondary	Microdialysis	Adipose tissue microdialysis	Baseline and 3 months	No
Secondary	Femoral subcutaneous adipose tissue biopsy	Biochemical, proteomics, metabolomics, genomics and morphological analyses	Baseline and 3 months	No