How Menopause Affects Lipid Metabolism in the Visceral Fat Depots

NCT02524457 | Unknown DMC

• 1 other identifier: H-3-2014-096
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Insulin Sensitivity and Lipid Metabolism

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  measured through a hyperinsulinemic euglycemic clamp (Outcome: glucose infusion rate)

  4 weeks

Study Arms (3)

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

Interventions

This is an observational study. There are no interventions OTHER

Postmenopausal; Postmenopausal + HT; Premenopausal

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• women
• years old
• for HT treated women (HT more than 1 year)

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Related Publications (2)

• 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.

  PMID: 23548615 BACKGROUND

• 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.

  PMID: 25000528 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood and fat biopsies

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

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

Study Officials

• Julie Abildgaard, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Abildgaard, MD

CONTACT

+4535457190; julie.abildgaard.01@regionh.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, phd-student

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 14, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2020
• Last Updated: August 14, 2015

Record last verified: 2015-08