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

NCT ID: NCT02076932

Last Updated: 2016-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-01-31

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.

Detailed Description

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Conditions

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Menopause Insulin Resistance Body Composition, Beneficial

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Premenopausal women

The premenopausal women will be attending Spinning classes.

Group Type ACTIVE_COMPARATOR

Spinning

Intervention Type 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

The postmenopausal women will be attending Spinning classes.

Group Type EXPERIMENTAL

Spinning

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

57 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Bente Merete Stallknecht

Professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ylva Hellsten, Proff.

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Bente M Stallknecht, Proff. MD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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Department og Biomedical Sciences

Copenhagen N, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CWS menopause, adipose tissue

Identifier Type: -

Identifier Source: org_study_id

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