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Clinical Trials/NCT00993603
NCT00993603
Completed
Not Applicable

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 Royal Bournemouth Hospital1 site in 1 country66 target enrollmentSeptember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
The Royal Bournemouth Hospital
Enrollment
66
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
13 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
October 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
The Royal Bournemouth Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • The secondary aim is to examine the changes in weight, cardiovascular risk factors and hormonal regulators of food intake and blood glucose metabolism.(8 months lifestyle programme)

Study Sites (1)

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