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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014