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Lifestyle Intervention in Patients With New Onset Type 2 Diabetes.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01402388
First Posted: July 26, 2011
Last Update Posted: July 26, 2011
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.
Information provided by:
The Royal Bournemouth Hospital
  Purpose
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 Intervention
Type 2 Diabetes Behavioral: Group lifestyle programme

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by The Royal Bournemouth Hospital:

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

Enrollment: 22
Study Start Date: October 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle intervention group. Behavioral: Group lifestyle programme

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Professor David Kerr, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01402388     History of Changes
Other Study ID Numbers: 07/H0201/100
First Submitted: July 25, 2011
First Posted: July 26, 2011
Last Update Posted: July 26, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases