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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. Identifier: NCT01402388
Recruitment Status : Completed
First Posted : July 26, 2011
Last Update Posted : July 26, 2011
Information provided by:
The Royal Bournemouth Hospital

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Group lifestyle programme Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Intensive Lifestyle Intervention on Hormonal Factors Regulating Food Intake and Blood Glucose Control in Patients With New Onset Type 2 Diabetes.
Study Start Date : October 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lifestyle intervention group. Behavioral: Group lifestyle programme

Primary Outcome Measures :
  1. Lifestyle impact on GLP-1, HbA1c and fasting glycaemia. [ Time Frame: 8 months following commencement of study. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: Professor David Kerr, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Identifier: NCT01402388    
Other Study ID Numbers: 07/H0201/100
First Posted: July 26, 2011    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2011
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases