Group Lifestyle Intervention for People With New Onset Type 2 Diabetes.

NCT00705952 | Completed

• 2 other identifiers: GLP4Health ("GLP-1")REC ref.: 07/H0201/100
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

No diabetes medications; New onset

Outcome Measures

Primary Outcomes (1)

• 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.

  8 months lifestyle programme

Secondary Outcomes (1)

• To examine the changes in hormonal regulators of energy homeostasis (leptin, adiponectin, ghrelin) and cardiovascular risk factors occurring with this intervention.

  8 months lifestyle programme

Study Arms (1)

1

EXPERIMENTAL

Other: Lifestyle intervention

Interventions

Lifestyle intervention OTHER

Diet, exercise and behavioural change intervention.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New onset of Type 2 Diabetes.
• BMI\>25kg/m2

You may not qualify if:

• Antiobesity, oral hypoglycaemic medications or any other prescription medications that may interfere with the study results
• Pregnancy
• Unable to converse competently in English as special arrangements would need to be made for such people and this would be impractical in a group setting
• Attending another weight management programme
• Patients who would be unable to attend all the programme sessions for medical or other reasons
• Any patients from groups listed in A24

Sponsors & Collaborators

• The Royal Bournemouth Hospital: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• David Kerr, professor

  Royal Bournemouth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 27, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: November 30, 2010

Record last verified: 2010-11