Lifestyle Intervention in Patients With New Onset Type 2 Diabetes.
July 25, 2011 updated by: The Royal Bournemouth Hospital
Effect of Intensive Lifestyle Intervention on Hormonal Factors Regulating Food Intake and Blood Glucose Control in Patients With New Onset Type 2 Diabetes.
The study seeks to establish if weight loss achieved through a program of intensive lifestyle management can result in improvements in GLP-1 and glycaemic control, in patients with newly diagnosed type 2 diabetes mellitus.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- New onset type 2 Diabetes
- Body mass index 25 and above
- Able to give informed consent
Exclusion Criteria:
- Hypoglycaemic and antiobesity agents, or any other prescription medication that may interfere with study results
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lifestyle intervention group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Lifestyle impact on GLP-1, HbA1c and fasting glycaemia.
Time Frame: 8 months following commencement of study.
|
8 months following commencement of study.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
July 25, 2011
First Submitted That Met QC Criteria
July 25, 2011
First Posted (Estimate)
July 26, 2011
Study Record Updates
Last Update Posted (Estimate)
July 26, 2011
Last Update Submitted That Met QC Criteria
July 25, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07/H0201/100
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.