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

NCT01531907 | Completed

• 1 other identifier: STH16160
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Acute responses of GLP-2 and bone resorption markers following feeding are affected by body fat mass.
2. 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. 3.GLP-2 has direct actions on osteoclast resorption via a functional receptor

Conditions

Obesity

Keywords

GLP2; Obesity; Premenopausal; Bone; Formation; Resorption

Outcome Measures

Primary Outcomes (1)

• GLP-2 levels

  Change at 20, 60 and 120 minutes

Secondary Outcomes (5)

• Osteocalcin levels

  Change at 20, 60 and 120 minutes

• β Carboxy-terminal collagen crosslinks (β CTx)levels

  Change at 20, 60 and 120 minutes

• Procollagen 1 N-terminal propeptide (P1NP) levels

  Change at 20, 60 and 120 minutes

• High-resolution peripheral quantitative computed tomography (HRpQCT)

  At baseline

• Dual-emission X-ray absorptiometry (DXA)

  At baseline

Study Arms (2)

Obese

Premenopausal women, 25 - 40 years with BMI of ≥30kg/m2

Other: Study visit procedures

Lean

Premenopausal women, 25 - 40 years with BMI of 18.5-24.9 kg/m2

Other: Study visit procedures

Interventions

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.

Lean; Obese

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will recruit healthy pre-menopausal, Caucasian female participants 25-40 years and divide them into two groups, obese and lean according to their Body Mass Index. Participants will be identified and approached from a study group of obese and lean participants previously recruited for the 'The Effects of Obesity on Bone Structure and Strength - Fat and Bone Study (FAB)' study (REC ref 10/H1308/61) conducted at the Academic Unit of Bone Metabolism (AUBM) in Sheffield. Participants from this study have been selected as some of the scan and neuromuscular function data generated from this study will be reused as explained below. Body Mass Index ≥30 kg/m2 will be used to define obesity with BMI for lean participants defined as 18.5-24.9 kg/m2. Thirty participants will be recruited, 15 obese and 15 lean. Participants will be matched for age, and where possible height.

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Academic Unit of Bone Metabolism

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

On completion of the study, serum and plasma aliquots will be moved to the Human Tissue Authority (HTA) licensed biorepository housed in the Centre for Biomedical Research.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Paul Dimitri, Dr

  Sheffield Childrens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 13, 2012
• Study Start: September 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

GB (1)