ObesityGLP-2NCT01531907
Relationships Between GLP-2 and Markers of Bone Turnover Following Feeding
An observational study of Obesity, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Study visit procedures
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2011to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Unit of Bone Metabolism
Sheffield, South Yorkshire, S5 7AU
About this study
Official title: Relationships Between GLP-2 and Markers of Bone Turnover Following Feeding: the Influence of Obesity and Cellular Mechanisms of Action
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
Read the detailed description
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
- Conditions
- Obesity
- Being tested
- Study visit procedures
- Keywords
- GLP2, Obesity, Premenopausal, Bone, Formation, Resorption
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study visit proceduresOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Obese | Premenopausal women, 25 - 40 years with BMI of ≥30kg/m2 Receives: Other: Study visit procedures | |
| Lean | Premenopausal women, 25 - 40 years with BMI of 18.5-24.9 kg/m2 Receives: Other: Study visit procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP-2 levels
Measured: Change at 20, 60 and 120 minutes
Secondary outcomes (5)
Osteocalcin levels
Measured: Change at 20, 60 and 120 minutes
β Carboxy-terminal collagen crosslinks (β CTx)levels
Measured: Change at 20, 60 and 120 minutes
Procollagen 1 N-terminal propeptide (P1NP) levels
Measured: Change at 20, 60 and 120 minutes
High-resolution peripheral quantitative computed tomography (HRpQCT)
Measured: At baseline
Dual-emission X-ray absorptiometry (DXA)
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Paul Dimitri, Dr, Principal investigator, Sheffield Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531907
- Sponsor's protocol ID
- STH16160
- Acronym
- GLP-2
- Status last verified
- Feb 2019
- First submitted
- 3 Feb 2012
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Between GLP-2 and Markers of Bone Turnover Following Feeding: the Influence of Obesity and Cellular Mechanisms of Action
- ClinicalTrials.gov ID
- NCT01531907
- Acronym / sponsor ID
- GLP-2 / STH16160
- Conditions
- Obesity
- Keywords
- GLP2, Obesity, Premenopausal, Bone, Formation, Resorption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- Sep 2011 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese | – | Other: Study visit proceduresPremenopausal women, 25 - 40 years with BMI of ≥30kg/m2 |
| Lean | – | Other: Study visit proceduresPremenopausal women, 25 - 40 years with BMI of 18.5-24.9 kg/m2 |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- Age 25-40
- Caucasian
- Premenopausal
- Able and willing to consent
- BMI either 18.5-24.9 kg/m2 or ≥30 kg/m2
Key exclusion criteria (23 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study visit proceduresAnthropometric 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. | Other | Lean, Obese |
Primary outcome
GLP-2 levels
Time frame: Change at 20, 60 and 120 minutes
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Dimitri, Dr principal investigator
Sheffield Childrens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GLP-2 levels (time frame: Change at 20, 60 and 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.