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

Primary Purpose

Menopause, Insulin Resistance, Body Composition, Beneficial

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Spinning
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Menopause

Eligibility Criteria

45 Years - 57 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department og Biomedical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Premenopausal women

Postmenopausal Women

Arm Description

The premenopausal women will be attending Spinning classes.

The postmenopausal women will be attending Spinning classes.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 24, 2014
Last Updated
May 31, 2016
Sponsor
University of Copenhagen
Collaborators
Rigshospitalet, Denmark, Glostrup University Hospital, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02076932
Brief Title
Effects of Physical Training on Adipose Tissue Metabolism and Insulin Sensitivity in the Menopausal Transition Phase
Official Title
A Training Intervention Study in Late Pre- and Early Postmenopausal Women Investigating the Changes in Adipose Tissue Metabolism and Peripheral Insulin Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Rigshospitalet, Denmark, Glostrup University Hospital, Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Insulin Resistance, Body Composition, Beneficial

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Premenopausal women
Arm Type
Active Comparator
Arm Description
The premenopausal women will be attending Spinning classes.
Arm Title
Postmenopausal Women
Arm Type
Experimental
Arm Description
The postmenopausal women will be attending Spinning classes.
Intervention Type
Behavioral
Intervention Name(s)
Spinning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insulin stimulated uptake of glucose in adipose tissue
Description
Measured by Positron Emission Tomography-Computed tomography (PET/CT)
Time Frame
Baseline and 3 months
Title
Hyperinsulinemic euglycemic clamp
Description
Glucose metabolized (mg/kg/min)
Time Frame
Baseline and 3 months
Title
Adipose tissue distribution
Description
Accessed by Magnetic Resonance Imaging (MRI).
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Central insulin sensitivity
Description
Fasting plasma insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test
Time Frame
Baseline and 3 months
Title
Maximal oxygen uptake (ml/O2/kg/min)
Description
Measured using indirect calorimetry and an incremental bicycle protocol
Time Frame
Baseline and 3 months
Title
Metabolic syndrome
Description
As measured by high density lipoprotein, triglycerides, waist circumference, blood pressure, mean arterial pressure, fasting glucose and composite metabolic syndrome scores
Time Frame
Baseline and 3 months
Title
Health related quality of life
Description
Measured using questionaries, semi-structured interviews and observations
Time Frame
Baseline and 3 months
Title
Anthropometry
Description
Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height
Time Frame
Baseline and 3 months
Title
Skeletal muscle biopsy
Description
Biochemical, proteomics, metabolomics, genomics and morphological analyses
Time Frame
Baseline and 3 months
Title
Abdominal subcutaneous adipose tissue biopsy
Description
Biochemical, proteomics, metabolomics, genomics and morphological analyses
Time Frame
Baseline and 3 months
Title
Resting metabolic rate
Description
Will be measured by indirect calorimetry
Time Frame
Baseline and 3 months
Title
Physical activity level and duration of sleep
Description
Daily activity and duration of sleep will be recorded during one week using Actibelt® and self reporting
Time Frame
Baseline and 3 months
Title
Microdialysis
Description
Adipose tissue microdialysis
Time Frame
Baseline and 3 months
Title
Femoral subcutaneous adipose tissue biopsy
Description
Biochemical, proteomics, metabolomics, genomics and morphological analyses
Time Frame
Baseline and 3 months
Other Pre-specified Outcome Measures:
Title
Dietary registration
Description
Daily food intake for three week days and one week-end day will be reported by the subjects
Time Frame
Baseline and 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
57 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: Smoking Excessive alcohol intake Regular medication including hormone replacement treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ylva Hellsten, Proff.
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bente M Stallknecht, Proff. MD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department og Biomedical Sciences
City
Copenhagen N
ZIP/Postal Code
2200
Country
Denmark

12. IPD Sharing Statement

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

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