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NCT Number: NCT01531907

Relationships Between GLP-2 and Markers of Bone Turnover Following Feeding

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

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Academic Unit of Bone Metabolism

Sheffield, South Yorkshire, S5 7AU, United Kingdom

About this study

Study objectives:

  • 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.
  • 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
  • To test whether GLP-2 directly affects osteoclast function via an identifiable receptor

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Study visit procedures

Other

Anthropometric measurements to include:

  • Weight, height, and BMI.
  • Waist and hip circumference
  • Triceps skinfold thickness
  • Measurement of supine abdominal thickness A baseline blood sample (15ml)is taken before receiving a standard polycal drink (75g glucose load) Three further blood samples (15 ml) will be taken, at the time points 20, 60 and 120 minutes after glucose loading. In 10 subjects (5 lean and 5 obese) we will take an additional blood sample (up to 50 ml) at baseline into heparin to grow osteoclasts in culture. Visit duration - approximately 3-4 hours.

Primary outcomes

  1. GLP-2 levels

    Time frame: Change at 20, 60 and 120 minutes

Secondary outcomes

  1. Osteocalcin levels

    Time frame: Change at 20, 60 and 120 minutes

  2. β Carboxy-terminal collagen crosslinks (β CTx)levels

    Time frame: Change at 20, 60 and 120 minutes

  3. Procollagen 1 N-terminal propeptide (P1NP) levels

    Time frame: Change at 20, 60 and 120 minutes

  4. High-resolution peripheral quantitative computed tomography (HRpQCT)

    Time frame: At baseline

  5. Dual-emission X-ray absorptiometry (DXA)

    Time frame: At baseline

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • University of Sheffield

Registry information

Official study title

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

Acronym: GLP-2

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 13, 2012
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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