- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00993603
Lifestyle Intervention in Obese Non-diabetic Adults With a Family History of Diabetes.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dorset
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Bournemouth, Dorset, United Kingdom, BH7 7DW
- Royal Bournemouth Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- BMI between 30-39.9kg/m2
- Family history of diabetes (self reported)
- Normal and impaired glucose tolerance
- Obtain informed consent
Exclusion criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifestyle programme.
8 month lifestyle programme.
|
Dietary and lifestyle counselling (11 sessions), weekly exercise programme and 3 fasting blood samples at baseline, 4 and 8 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
8 month lifestyle programme
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
8 months lifestyle programme
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr Joe Begley, The Royal Bournemouth Hospitals
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Non-DM Lifestyle.
- REC reference: 09/H0504/61
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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