Group Lifestyle Intervention for People With New Onset Type 2 Diabetes. (GLP4Health)
The purpose of the study is to assess whether weight loss achieved through a programme of intensive lifestyle management can result in enhanced production of Glucagon-Like Peptide-1 (GLP-1) together with improvements in the release of insulin and glucagon and thus improvements in glycaemic control (HbA1c), in patients with new onset type 2 diabetes.
This is a cohort study with comparisons made between assessments at baseline, after an initial four months of intensive intervention and after a further four months follow up (maintenance period). Each patient will participate in the study for 8 month. The entire study period will be 24 months.
All patients with new onset type 2 diabetes (within 2 weeks of diagnosis) will be recruited from those referred to the Type 2 Diabetes Education Programme in the community ("FOCUS"), as per standard practice. The investigators will also hope to recruit direct from local GP surgeries who will be advised of the study. At this point, patients will be given a study information sheet with a contact number if they wish to participate in the study.
Individuals who are unable to give consent, who would be unable to attend all the programme sessions for medical or other reasons, who are prescribed oral hypoglycaemic, antiobesity or any other prescription medications that may interfere with the study results or whose BMI is < 25, will be excluded. The investigators will also exclude those who cannot converse competently in English as special arrangements would need to be made for such people attending the programme and this would be impractical in a group setting.
Those willing to participate will be invited for an individual appointment with the dietitian, during which the study structure, aims and procedures will be explained and consent to participate in the study will be obtained. For the first session of the programme, participants will be asked to attend following an overnight fast. Blood samples will be taken for basal measurement of glucose, HbA1c, lipids, insulin, glucagon, GLP-1, leptin, ghrelin and adiponectin. They will then be given a standard 75 g glucose load and sampling repeated at 30 mins (for peak GLP-1 levels). Baseline measurements of weight, height, percent body fat, waistline circumference and blood pressure will also be taken during this session. Following the assessment, patients will participate in the first session of the education programme. The full assessment will be repeated at 4 and 8 months intervals.
The weight management programme will be run by the Specialist Dietitian. It will consist of 2 phases: an initial 4 month intensive weight loss phase, followed by a 4 month weight loss / maintenance phase. The initial four month programme will consist of 8 group education sessions and at least 3 phone calls. The following 4 month programme will consist of 5 group sessions, at least 3 phone calls and 1 individual appointment. Each education session will last 60min. Before the 1st session and, at 4 month and 8 month sessions, bloods will be taken, as above. Before the rest of the sessions, there will be 15 minutes devoted to weight assessment. The programme will be based on portion control and healthy eating and will be supported by behavioural and cognitive change interventions. Such interventions will include self monitoring, stimulus control, goal setting, problem solving and relapse prevention. The specialists from "Bournemouth HealthLink" (a partnership backed by the local NHS, Council and University) will take part in helping participants to increase their activity levels.
The aim is to achieve weight loss of 5% over the first 4 months with, as a minimum, weight maintenance or possible further reduction over the subsequent four months.
|Study Design:||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.|
- Whether weight loss achieved through a programme of intensive lifestyle management can result in enhanced production of Glucagon-Like Peptide-1 together with improvements in glycaemic control, in patients with new onset type 2 diabetes. [ Time Frame: 8 months lifestyle programme ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||January 2008|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Other: Lifestyle intervention
Diet, exercise and behavioural change intervention.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00705952
|Principal Investigator:||David Kerr, professor||Royal Bournemouth Hospital|