How Menopause Affects Lipid Metabolism in the Visceral Fat Depots

Insulin Sensitivity and Lipid Metabolism Clinical Trial

Official title:

How Menopause Affects Lipid Metabolism in the Visceral Fat Depots

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02524457
• Other study ID #: H-3-2014-096
• Status: Not yet recruiting
• Phase: N/A
• First received: August 11, 2015
• Last updated: August 13, 2015
• Start date: September 2015
• Est. completion date: September 2020

Study information

• Verified date: August 2015
• Source: Rigshospitalet, Denmark
• Contact: Julie Abildgaard, MD
• Phone: +4535457190
• Email: julie.abildgaard.01[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2020
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 55 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Insulin Sensitivity and Lipid Metabolism

Intervention

Other:
• This is an observational study. There are no interventions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity	measured through a hyperinsulinemic euglycemic clamp (Outcome: glucose infusion rate)	4 weeks	No