How Menopause Affects Lipid Metabolism in the Visceral Fat Depots

August 13, 2015 updated by: Anders Rasmussen Rinnov, Rigshospitalet, Denmark
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women from 45-55 years of age undergoing gynecological surgery for benign reasons.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Premenopausal
Premenopausal women going through gynecological surgery
Other: This is an observational study. There are no interventions
Postmenopausal
Postemnopausal women going through gynecological surgery
Other: This is an observational study. There are no interventions
Postmenopausal + HT
Postmenopausal women going through gynecological surgery who has been taking hormone treatment through the past year (as a minimum)
Other: This is an observational study. There are no interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin sensitivity
Time Frame: 4 weeks
measured through a hyperinsulinemic euglycemic clamp (Outcome: glucose infusion rate)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Julie Abildgaard, MD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Estimate)

August 14, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2014-096

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insulin Sensitivity and Lipid Metabolism

Clinical Trials on This is an observational study. There are no interventions

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe