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

NCT02076932 | Completed

• 1 other identifier: CWS menopause, adipose tissue
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Insulin Resistance; Body Composition, Beneficial

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Central insulin sensitivity

  Baseline and 3 months

• Maximal oxygen uptake (ml/O2/kg/min)

  Baseline and 3 months

• Metabolic syndrome

  Baseline and 3 months

• Health related quality of life

  Baseline and 3 months

• Anthropometry

  Baseline and 3 months

Other Outcomes (1)

• Dietary registration

  Baseline and 3 months

Study Arms (2)

Premenopausal women

ACTIVE COMPARATOR

The premenopausal women will be attending Spinning classes.

Behavioral: Spinning

Postmenopausal Women

EXPERIMENTAL

The postmenopausal women will be attending Spinning classes.

Behavioral: Spinning

Interventions

Spinning BEHAVIORAL

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.

Postmenopausal Women; Premenopausal women

Eligibility Criteria

• Age: 45 Years - 57 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Copenhagen: lead
• Rigshospitalet, Denmark: collaborator
• Glostrup University Hospital, Copenhagen: collaborator

Study Sites (1)

Department og Biomedical Sciences

Copenhagen N, 2200, Denmark

Location

MeSH Terms

Conditions

Insulin Resistance; Glucocorticoid Receptor Deficiency

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ylva Hellsten, Proff.

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

• Bente M Stallknecht, Proff. MD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: March 4, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

DK (1)