Relationships Between GLP-2 and Markers of Bone Turnover Following Feeding (GLP-2)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01531907 |
Recruitment Status :
Completed
First Posted : February 13, 2012
Last Update Posted : February 15, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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:
- Acute responses of GLP-2 and bone resorption markers following feeding are affected by body fat mass.
- 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
- GLP-2 has direct actions on osteoclast resorption via a functional receptor
Condition or disease | Intervention/treatment |
---|---|
Obesity | Other: Study visit procedures |
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
Study Type : | Observational |
Actual Enrollment : | 19 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Relationships Between GLP-2 and Markers of Bone Turnover Following Feeding: the Influence of Obesity and Cellular Mechanisms of Action |
Actual Study Start Date : | September 2011 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | July 2014 |
Group/Cohort | Intervention/treatment |
---|---|
Obese
Premenopausal women, 25 - 40 years with BMI of ≥30kg/m2
|
Other: Study visit procedures
Anthropometric measurements to include:
|
Lean
Premenopausal women, 25 - 40 years with BMI of 18.5-24.9 kg/m2
|
Other: Study visit procedures
Anthropometric measurements to include:
|
- GLP-2 levels [ Time Frame: Change at 20, 60 and 120 minutes ]
- Osteocalcin levels [ Time Frame: Change at 20, 60 and 120 minutes ]
- β Carboxy-terminal collagen crosslinks (β CTx)levels [ Time Frame: Change at 20, 60 and 120 minutes ]
- Procollagen 1 N-terminal propeptide (P1NP) levels [ Time Frame: Change at 20, 60 and 120 minutes ]
- High-resolution peripheral quantitative computed tomography (HRpQCT) [ Time Frame: At baseline ]
- Dual-emission X-ray absorptiometry (DXA) [ Time Frame: At baseline ]
Biospecimen Retention: Samples Without DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 25 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531907
United Kingdom | |
Academic Unit of Bone Metabolism | |
Sheffield, South Yorkshire, United Kingdom, S5 7AU |
Principal Investigator: | Paul Dimitri, Dr | Sheffield Childrens Hospital |
Responsible Party: | Sheffield Teaching Hospitals NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT01531907 |
Other Study ID Numbers: |
STH16160 |
First Posted: | February 13, 2012 Key Record Dates |
Last Update Posted: | February 15, 2019 |
Last Verified: | February 2019 |
GLP2 Obesity Premenopausal |
Bone Formation Resorption |
Obesity Overnutrition Nutrition Disorders Overweight Body Weight |