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临床试验/NCT01531907
NCT01531907已完成不适用

Relationships Between GLP-2 and Markers of Bone Turnover Following Feeding: the Influence of Obesity and Cellular Mechanisms of Action

Sheffield Teaching Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2011年9月最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
GLP-2 levels
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study has been designed to study differences bone turnover in relation to glucagon-like peptide-2 (GLP-2) following feeding in lean and obese premenopausal women. Given the preliminary evidence that GLP-2 may act directly on osteoclasts, the investigators plan to determine whether GLP2 receptors are expressed in osteoclasts and the effect of GLP-2 on bone resorption.

Hypotheses:

  1. Acute responses of GLP-2 and bone resorption markers following feeding are affected by body fat mass.
  2. Serum levels of GLP-2 are lower in obese pre-menopausal women and are associated with a reduction in trabecular and/or cortical bone mass
  3. GLP-2 has direct actions on osteoclast resorption via a functional receptor

详细描述

Study objectives:

  1. To determine if differences in baseline serum levels of GLP-2 are related to differences in bone microarchitecture, structure and strength at the distal tibia and distal radius between obese and lean premenopausal females.
  2. To determine whether obesity in premenopausal females influences levels of circulating GLP-2 following a standardised glucose meal with a resultant change in markers of bone formation and resorption
  3. To test whether GLP-2 directly affects osteoclast function via an identifiable receptor

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
25 Years 至 40 Years（Adult）
性别
Female
接受健康志愿者
是

入选标准

  • •Age 25-40
  • •Caucasian
  • •Premenopausal
  • •Able and willing to consent
  • •BMI either 18.5-24.9 kg/m2 or ≥30 kg/m2
  • •Completion 'The Effects of Obesity on Bone Structure and Strength' study REC ref 10/H1308/61
  • •Consented to be approached for future research studies

排除标准

  • •Fracture less than twelve months prior to recruitment
  • •History of any long term immobilization (duration greater than three months)
  • •Current pregnancy or trying to conceive Pregnancy or breast feeding less than one year prior to recruitment
  • •Diabetes mellitus
  • •History of or current conditions known to affect bone metabolism, which may include:
  • •Diagnosed skeletal disease or osteoarthritis
  • •Chronic renal disease
  • •Acute or chronic hepatic disease
  • •Hyperparathyroidism or Hyperthyroidism
  • •Malabsorption syndromes
  • •Diagnosed endocrine disorders
  • •Diagnosed diabetes mellitus
  • •Clinically significant hypocalcemia or hypercalcemia
  • •Diagnosed restrictive eating disorder
  • •Current or clinically significant previous use of medications or treatment known to affect bone metabolism, for example:
  • •Depot medroxyprogesterone or the combined oral contraceptive pill
  • •Glucocorticoid therapy
  • •Anti-convulsant therapy
  • •Bone treatments (e.g. Bisphosphonates)
  • •Alcohol intake of greater than 21 units per week
  • •Athlete, defined as an individual participating in competitive sport at amateur or professional level
  • •Monogenic and obesity syndromes
  • •History of cancer within the past 5 years excluding skin cancer non melanomas

结局指标

主要结局

GLP-2 levels

时间窗: Change at 20, 60 and 120 minutes

次要结局

  • Osteocalcin levels(Change at 20, 60 and 120 minutes)
  • β Carboxy-terminal collagen crosslinks (β CTx)levels(Change at 20, 60 and 120 minutes)
  • High-resolution peripheral quantitative computed tomography (HRpQCT)(At baseline)
  • Procollagen 1 N-terminal propeptide (P1NP) levels(Change at 20, 60 and 120 minutes)
  • Dual-emission X-ray absorptiometry (DXA)(At baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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