Lifestyle Intervention in Patients With New Onset Type 2 Diabetes.

This study has been completed.
Sponsor:
Information provided by:
The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier:
NCT01402388
First received: July 25, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

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
Study First Received: July 25, 2011
Last Updated: July 25, 2011
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on April 16, 2014