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Lifestyle Intervention in Patients With New Onset Type 2 Diabetes.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01402388
Recruitment Status : Completed
First Posted : July 26, 2011
Last Update Posted : July 26, 2011
Sponsor:
Information provided by:
The Royal Bournemouth Hospital

Tracking Information
First Submitted Date  ICMJE July 25, 2011
First Posted Date  ICMJE July 26, 2011
Last Update Posted Date July 26, 2011
Study Start Date  ICMJE October 2007
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
Lifestyle impact on GLP-1, HbA1c and fasting glycaemia. [ Time Frame: 8 months following commencement of study. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifestyle Intervention in Patients With New Onset Type 2 Diabetes.
Official Title  ICMJE Effect of Intensive Lifestyle Intervention on Hormonal Factors Regulating Food Intake and Blood Glucose Control in Patients With New Onset Type 2 Diabetes.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE Behavioral: Group lifestyle programme
Study Arms  ICMJE Experimental: Lifestyle intervention group.
Intervention: Behavioral: Group lifestyle programme
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2011)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01402388
Other Study ID Numbers  ICMJE 07/H0201/100
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor David Kerr, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Study Sponsor  ICMJE The Royal Bournemouth Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Royal Bournemouth Hospital
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP