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临床试验/NCT03856268
NCT03856268撤回不适用

Understanding the Roles of Estradiol and Follicle-stimulating Hormone in Adipocyte Remodeling Following Surgical and Pharmacology-induced Menopause (RESUME-2 Study)

Pennington Biomedical Research Center1 个研究点 分布在 1 个国家开始时间: 2019年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Rate of in vivo adipogenesis (via deuterium-enrichment of adipose tissue DNA)

研究概览

简要总结

The overarching aims of this study are to:

  1. Characterize the rate of in vivo adipogenesis, and changes in adipose tissue gene and protein expression, in the scABD and scFEM depots of women undergoing surgical menopause (↓E2, ↑FSH).
  2. Characterize the rate of in vivo adipogenesis, and changes in adipose tissue gene and protein expression, in the scABD and scFEM depots of women undergoing gonadal suppression (↓E2, ↓FSH).

详细描述

This is a cross-sectional study where two groups of premenopausal women (ages 18-50 y) will be enrolled in a parallel arm study:

  • Arm 1 (Surgical Menopause): up to 6 women undergoing laparoscopic, elective bilateral oophorectomy [Site: Pennington Biomedical Research Center].
  • Arm 2 (Pharmacology-Induced Menopause): up to 6 women undergoing gonadal suppression via leuprolide acetate (Lupron [AbbVie Inc.]) [Site: UC-Denver].

We will compare each arm of women to non-oophorectomized, premenopausal women (controls) with normal menstrual cycles (Apple&Pear study; NCT01748994; PI: Ravussin) selectively matched (1:2) for age and BMI. The Apple&Pear study uses the same in vivo adipogenesis labeling protocol, with similar age and BMI criteria, as the proposed study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

ARM 1: 'Surgical Menopause' Group

Premenopausal women having an oophorectomy.

干预措施: 'Surgical Menopause' Group (Procedure)

ARM 2: "Drug-Induced Menopause'

Premenopausal women with gonadal suppression

干预措施: 'Drug-Induced Menopause' Group (Drug)

结局指标

主要结局

Rate of in vivo adipogenesis (via deuterium-enrichment of adipose tissue DNA)

时间窗: Change from baseline in enrichment of DNA of adipose cells with deuterium at 8 weeks

Deuterium from the deuterium-labeled water is incorporated into the newly-synthesized DNA of newly-formed fat cell precursor cells through cell replication. The latter carry over the label when they become fat cells through differentiation. Enzymatic digestion of the fat tissue isolates the individual cells constituting the fat tissue. Centrifugation of the cell suspension allows the separation of fat cells into a floating layer and a pellet comprised of stromal-vascular cells including the fat cell precursor cells and small fat cells. As the fat cell precursor cells and small adipocytes have the property to attach quickly to plastic surfaces of culture dishes, a brief culturing of the stromal-vascular cells sorts these cells from the remaining cells. Thus, measuring the deuterium-enrichment of DNA from plastic-adherent stromal-vascular cells indicates the rate of in vivo formation of new mature fat cells and pre-adipocytes, a process collectively termed adipogenesis.

次要结局

  • Size of adipocytes(Change from baseline in size of adipocytes at 8 weeks post-surgery)
  • Body composition (by Dual-energy X-ray Absorptiometry (DXA))(Change from baseline in body composition at 8 weeks post-surgery)
  • Number of adipocytes(Change from baseline in number of adipocytes at 8 weeks post-surgery)
  • Adipose tissue gene and protein expression(Changes from baseline in gene and protein expression at 8 weeks post-surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kara Marlatt

Postdoctoral Researcher - John S McIlhenny Skeletal Muscle Physiology - Ravussin

Pennington Biomedical Research Center

研究点 (1)

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