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

Study Overview
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Brief Summary
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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.

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

Conditions
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Body Composition, Beneficial, Menopause, Insulin Resistance

Intervention / Treatment
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* Behavioral: Spinning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 57 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Premenopausal women<br>The premenopausal women will be attending Spinning classes. | Behavioral: Spinning<br>* 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.<br>|
| Experimental: Postmenopausal Women<br>The postmenopausal women will be attending Spinning classes. | Behavioral: Spinning<br>* 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.<br>|

What is the study measuring?
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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 |