Group Lifestyle Intervention (GLP4Health) for People With New Onset Type 2 Diabetes - Full Text View

Sponsored by:	The Royal Bournemouth Hospital
Information provided by:	The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier:	NCT00705952

Purpose

The aim of the study is to see if a structured Group Lifestyle Programme can help to maintain, or reduce body weight in Type 2 diabetics started on new medication, known to increase body weight. The programme consists of an individual plan, group support and organised exercise programme.

Condition	Intervention
Type 2 Diabetes	Other: Lifestyle intervention

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Single Group Assignment
Official Title:	Effect Of Intensive Lifestyle Intervention On Hormonal Factors Regulating Food Intake And Blood Glucose Control And In Patients With New Onset Type 2 Diabetes

Further study details as provided by The Royal Bournemouth Hospital:

Primary Outcome Measures:

To determine whether weight loss achieved through a programme of intensive lifestyle management can result in enhanced Glucagon Like Peptide-1 (GLP-1) production and improvements in glycaemic control, in patients with new onset type 2 diabetes. [ Time Frame: 8 months lifestyle programme ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To examine the changes in hormonal regulators of energy homeostasis (leptin, adiponectin, ghrelin) and cardiovascular risk factors occurring with this intervention. [ Time Frame: 8 months lifestyle programme ] [ Designated as safety issue: No ]

Enrollment:	3
Study Start Date:	January 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Other: Lifestyle intervention Diet, exercise and behavioural change intervention.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

New onset of Type 2 Diabetes.
No diabetes medications
BMI>25kg/m2

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705952

Sponsors and Collaborators

The Royal Bournemouth Hospital

Investigators

Principal Investigator:

David Kerr, professor

Royal Bournemouth Hospital

More Information

Responsible Party:	The Royal Bournemouth Hospital ( Professor David Kerr )
Study ID Numbers:	GLP4Health NOD ("GLP-1"), REC ref.: 07/H0201/100
Study First Received:	June 24, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00705952
Health Authority:	United Kingdom: National Health Service

Keywords provided by The Royal Bournemouth Hospital:

No diabetes medications
New onset

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009