Type 2 DiabetesNCT00993603
Lifestyle Intervention in Obese Non-diabetic Adults With a Family History of Diabetes.
A study testing 8-month group lifestyle programme in people with Type 2 Diabetes and Obesity, run by The Royal Bournemouth Hospital at 1 site in United Kingdom.
Trial summary
The aim of this study is to investigate weather gradual weight loss achieved with healthy lifestyle changes influence hormonal factors affecting appetite and blood glucose control in obese people without presence of diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- 8-month group lifestyle programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Oct 2012
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 30-39.9kg/m2
- Family history of diabetes (self reported)
- Normal and impaired glucose tolerance
- Obtain informed consent
Who cannot join
- BMI less than 30kg/m2 or more than 39.9kg/m2
- Presence of diabetes or any other chronic disease or disability that might interfere with the study results
- Anti-obesity or any other prescription medications that may interfere with the study results
- Pregnancy
- Unable to converse competently in English as special arrangements would need to be made for such people and this would be impractical in a group setting
- Attending another weight management programme
- Patients who would be unable to attend at least 75% of the programme sessions for medical or other reasons
- Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW
About this study
Official title: The Effect of an 8-month Intensive Lifestyle Intervention on Hormonal Factors Regulating Food Intake in Obese, Non-diabetic Adults With a Family History of Diabetes.
The aim of this study is to investigate weather gradual weight loss achieved with healthy lifestyle changes influence hormonal factors affecting appetite and blood glucose control in obese people without presence of diabetes.
Read the detailed description
Obesity is becoming a growing and significant public health problem. Evidence from various national surveys over the last 25 years show that the prevalence of obesity and overweight in adults in England has increased threefold. There is still no clear evidence available to explain the epidemic levels of obesity. A number of neuro-endocrine factors have a role in the regulation of food intake and in the control of insulin secretion. We are particularly interested in measuring levels of a hormone called Glucagon-like peptide 1 (GLP-1) which is released from the intestine when food is absorbed. This hormone in turn has an influence on the production of insulin and another hormone, glucagons, both of which are involved in controlling blood glucose ('blood sugar') levels and appetite control.
There is some evidence, that obese people with normal blood sugar control show attenuated GLP-1 levels, however the evidence is contradictive and statistical significance is unclear. There is an ample of evidence that in established diabetes GLP-1 levels are attenuated, however it still remains uncertain whether the lower GLP-1 levels contribute to the pathogenesis of the condition or are a consequence of chronic hyperglycaemia or other hormonal and metabolic changes, though the observation that GLP-1 levels are lower in obese subjects suggests the possibility that the former may be the case.
Recently Bournemouth Diabetes and Emdocrine Centre (BDEC) conducted a research trial on effect of weight loss on GLP-1 levels in subjects with new onset type 2 diabetes. After 8 months intensive lifestyle programme average weight loss was 7.8 kg with significant and sustained improvements in clinical and metabolic parameters. Despite this, the GLP-1 levels remained unchanged.
None of the previous studies looked how gradual healthy lifestyle changes with sensible weight loss goals and increased activity levels effect GLP-1 levels in obese non-diabetic population.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- 8-month group lifestyle programme
- Keywords
- Lifestyle, Diabetes Mellitus, prevention/onset delay.
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-month group lifestyle programmeBehavioural
Dietary and lifestyle counselling (11 sessions), weekly exercise programme and 3 fasting blood samples at baseline, 4 and 8 months.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle programme. | Experimental | 8 month lifestyle programme. Receives: Behavioral: 8-month group lifestyle programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the correlation between weight loss over 8 months achieved through a programme of intensive lifestyle management and changes in GLP-1 production over the same period in obese without presence of diabetes but with family history of diabetes.
Measured: 8 month lifestyle programme
Secondary outcomes (1)
The secondary aim is to examine the changes in weight, cardiovascular risk factors and hormonal regulators of food intake and blood glucose metabolism.
Measured: 8 months lifestyle programme
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startSep 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Bournemouth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Joe Begley, Principal investigator, The Royal Bournemouth Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993603
- Sponsor's protocol ID
- Non-DM Lifestyle.
- Other IDs
- REC reference: 09/H0504/61
- Status last verified
- Dec 2012
- First submitted
- 9 Oct 2009
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an 8-month Intensive Lifestyle Intervention on Hormonal Factors Regulating Food Intake in Obese, Non-diabetic Adults With a Family History of Diabetes.
- ClinicalTrials.gov ID
- NCT00993603
- Acronym / sponsor ID
- Non-DM Lifestyle.
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- Lifestyle, Diabetes Mellitus, prevention/onset delay.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- The Royal Bournemouth HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 12 Oct 2009 (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.
The aim of this study is to investigate weather gradual weight loss achieved with healthy lifestyle changes influence hormonal factors affecting appetite and blood glucose control in obese people without presence of diabetes.
Detailed description
Obesity is becoming a growing and significant public health problem. Evidence from various national surveys over the last 25 years show that the prevalence of obesity and overweight in adults in England has increased threefold. There is still no clear evidence available to explain the epidemic levels of obesity. A number of neuro-endocrine factors have a role in the regulation of food intake and in the control of insulin secretion. We are particularly interested in measuring levels of a hormone called Glucagon-like peptide 1 (GLP-1) which is released from the intestine when food is absorbed. This hormone in turn has an influence on the production of insulin and another hormone, glucagons, both of which are involved in controlling blood glucose ('blood sugar') levels and appetite control.
There is some evidence, that obese people with normal blood sugar control show attenuated GLP-1 levels, however the evidence is contradictive and statistical significance is unclear. There is an ample of evidence that in established diabetes GLP-1 levels are attenuated, however it still remains uncertain whether the lower GLP-1 levels contribute to the pathogenesis of the condition or are a consequence of chronic hyperglycaemia or other hormonal and metabolic changes, though the observation that GLP-1 levels are lower in obese subjects suggests the possibility that the former may be the case.
Recently Bournemouth Diabetes and Emdocrine Centre (BDEC) conducted a research trial on effect of weight loss on GLP-1 levels in subjects with new onset type 2 diabetes. After 8 months intensive lifestyle programme average weight loss was 7.8 kg with significant and sustained improvements in clinical and metabolic parameters. Despite this, the GLP-1 levels remained unchanged.
None of the previous studies looked how gradual healthy lifestyle changes with sensible weight loss goals and increased activity levels effect GLP-1 levels in obese non-diabetic population.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle programme. | Experimental | Behavioral: 8-month group lifestyle programme8 month lifestyle programme. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI between 30-39.9kg/m2
- Family history of diabetes (self reported)
- Normal and impaired glucose tolerance
- Obtain informed consent
Key exclusion criteria (8 listed)
- BMI less than 30kg/m2 or more than 39.9kg/m2
- Presence of diabetes or any other chronic disease or disability that might interfere with the study results
- Anti-obesity or any other prescription medications that may interfere with the study results
- Pregnancy
- Unable to converse competently in English as special arrangements would need to be made for such people and this would be impractical in a group setting
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 |
|---|---|---|
| 8-month group lifestyle programmeDietary and lifestyle counselling (11 sessions), weekly exercise programme and 3 fasting blood samples at baseline, 4 and 8 months. | Behavioural | Lifestyle programme. |
Primary outcome
To estimate the correlation between weight loss over 8 months achieved through a programme of intensive lifestyle management and changes in GLP-1 production over the same period in obese without presence of diabetes but with family history of diabetes.
Time frame: 8 month lifestyle programme
1 secondary outcome
The secondary aim is to examine the changes in weight, cardiovascular risk factors and hormonal regulators of food intake and blood glucose metabolism.
Time frame: 8 months lifestyle programme
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 5 Dec 2012.
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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.
Dr Joe Begley principal investigator
The Royal Bournemouth Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8-month group lifestyle programme in people with Type 2 Diabetes and Obesity, run by The Royal Bournemouth Hospital 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 4 inclusion and 8 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 5 Dec 2012. 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?
To estimate the correlation between weight loss over 8 months achieved through a programme of intensive lifestyle management and changes in GLP-1 production over the same period in obese without presence of diabetes but with family history of diabetes. (time frame: 8 month lifestyle programme). 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 5 Dec 2012.