MedDataX Logo

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

NCT ID: NCT00993603

Last Updated: 2012-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Obesity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Lifestyle Diabetes Mellitus prevention/onset delay.

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lifestyle programme.

8 month lifestyle programme.

Group Type EXPERIMENTAL

8-month group lifestyle programme

Intervention Type BEHAVIORAL

Dietary and lifestyle counselling (11 sessions), weekly exercise programme and 3 fasting blood samples at baseline, 4 and 8 months.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Royal Bournemouth Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dr Joe Begley

Role: PRINCIPAL_INVESTIGATOR

The Royal Bournemouth Hospitals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royal Bournemouth Hospital

Bournemouth, Dorset, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC reference: 09/H0504/61

Identifier Type: -

Identifier Source: secondary_id

Non-DM Lifestyle.

Identifier Type: -

Identifier Source: org_study_id