Lifestyle Intervention in Obese Non-diabetic Adults With a Family History of Diabetes.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier:
NCT00993603
First received: October 9, 2009
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Obesity
Behavioral: 8-month group lifestyle programme

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by The Royal Bournemouth Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: September 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle programme.
8 month lifestyle programme.
Behavioral: 8-month group lifestyle programme
Dietary and lifestyle counselling (11 sessions), weekly exercise programme and 3 fasting blood samples at baseline, 4 and 8 months.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. BMI between 30-39.9kg/m2
  2. Family history of diabetes (self reported)
  3. Normal and impaired glucose tolerance
  4. Obtain informed consent

Exclusion criteria:

  1. BMI less than 30kg/m2 or more than 39.9kg/m2
  2. Presence of diabetes or any other chronic disease or disability that might interfere with the study results
  3. Anti-obesity or any other prescription medications that may interfere with the study results
  4. Pregnancy
  5. 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
  6. Attending another weight management programme
  7. Patients who would be unable to attend at least 75% of the programme sessions for medical or other reasons
  8. Unable to provide informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993603

Locations
United Kingdom
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom, BH7 7DW
Sponsors and Collaborators
The Royal Bournemouth Hospital
Investigators
Principal Investigator: Dr Joe Begley The Royal Bournemouth Hospitals
  More Information

No publications provided

Responsible Party: The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier: NCT00993603     History of Changes
Other Study ID Numbers: Non-DM Lifestyle., REC reference: 09/H0504/61
Study First Received: October 9, 2009
Last Updated: December 4, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by The Royal Bournemouth Hospital:
Lifestyle
Diabetes Mellitus
prevention/onset delay.

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014