How Menopause Affects Lipid Metabolism in the Visceral Fat Depots

NCT ID: NCT02524457

Last Updated: 2015-08-14

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

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2020-09-30

Brief Summary

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The purpose of the study is to describe the molecular mechanisms related to an increased visceral fat mass and changed T-cell homeostasis. the project is expected to add new knowledge to the field of metabolic diseases after menopause and increase the focus of how lipid affects the development of metabolic disease in relation to the menopausal transition.

Detailed Description

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The study is a cross sectional study including 60 women between 45 and 55 years of age. Investigators aim to include 20 premenopausal women, 20 postmenopausal women and 20 postmenopausal women taking hormone treatment (HT). All the women are going through gynecological surgery for benign reasons. During the operation investigators will take a visceral fat biopsy from the omentum.

maximally 1 month before- or after the operation the subject will meet at the lab for further testing, including:

* Health examination
* Blood samples
* OGTT
* DXA scan
* VO2 max testing
* MRI of the abdomen
* hyperinsulinemic euglycemic clamp

Conditions

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Insulin Sensitivity and Lipid Metabolism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Premenopausal

Premenopausal women going through gynecological surgery

This is an observational study. There are no interventions

Intervention Type OTHER

Postmenopausal

Postemnopausal women going through gynecological surgery

This is an observational study. There are no interventions

Intervention Type OTHER

Postmenopausal + HT

Postmenopausal women going through gynecological surgery who has been taking hormone treatment through the past year (as a minimum)

This is an observational study. There are no interventions

Intervention Type OTHER

Interventions

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This is an observational study. There are no interventions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* women
* 45-55 years old
* for HT treated women (HT more than 1 year)

Exclusion Criteria

* Infections during the last month
* chronic disease
* claustrophobia
* smoking
* Alcoholic intake \> 14 servings
* hysterectomy before menopause
* oophorectomized
* early menopause (before 40 yrs)
* BMI \> 30
Minimum Eligible Age

45 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Anders Rasmussen Rinnov

MD, phd-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie Abildgaard, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Central Contacts

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Julie Abildgaard, MD

Role: CONTACT

+4535457190

References

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Abildgaard J, Pedersen AT, Green CJ, Harder-Lauridsen NM, Solomon TP, Thomsen C, Juul A, Pedersen M, Pedersen JT, Mortensen OH, Pilegaard H, Pedersen BK, Lindegaard B. Menopause is associated with decreased whole body fat oxidation during exercise. Am J Physiol Endocrinol Metab. 2013 Jun 1;304(11):E1227-36. doi: 10.1152/ajpendo.00492.2012. Epub 2013 Apr 2.

Reference Type BACKGROUND
PMID: 23548615 (View on PubMed)

Abildgaard J, Henstridge DC, Pedersen AT, Langley KG, Scheele C, Pedersen BK, Lindegaard B. In vitro palmitate treatment of myotubes from postmenopausal women leads to ceramide accumulation, inflammation and affected insulin signaling. PLoS One. 2014 Jul 7;9(7):e101555. doi: 10.1371/journal.pone.0101555. eCollection 2014.

Reference Type BACKGROUND
PMID: 25000528 (View on PubMed)

Other Identifiers

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H-3-2014-096

Identifier Type: -

Identifier Source: org_study_id

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