LOADD (Lifestyle Over and Above Drugs in Diabetes) Study

Type 2 Diabetes Mellitus Clinical Trial

Official title:

The Potential for Diet Modification to Improve Glycaemic Control and Cardiovascular Risk Factors Over and Above Drug Therapy in Type 2 Diabetes at High Risk of Cardiovascular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00124553
• Other study ID #: ENCDR_1
• Status: Recruiting
• Phase: N/A
• First received: July 27, 2005
• Last updated: March 27, 2007
• Start date: August 2006
• Est. completion date: June 2008

Study information

• Verified date: March 2007
• Source: Edgar National Centre for Diabetes Research
• Contact: Chris S Booker, BSc(Hons)
• Phone: 64-3-474-7775
• Email: chris.booker[@]stonebow.otago.ac.nz
• Is FDA regulated: No
• Health authority: New Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial Summary

In the past, nutritional management formed the cornerstone of treatment of type 2 diabetes (T2DM). More recently, this aspect of treatment has received less attention as drug therapy aimed not only to lower glucose, but also to treat raised blood pressure and blood fats (including cholesterol) has been more widespread. While there is evidence to suggest that blood pressure and blood fat levels have improved, overall diabetes control has not and people with diabetes appear to be becoming progressively more overweight, following trends in the general population. The proposed study involves a randomised controlled trial in which people with T2DM continuing with their regular drug treatment and surveillance, will be randomly allocated to additionally receive intensive advice regarding diet or remain on their usual treatment in this regard. The results will be judged principally in terms of body weight, waist circumference, blood pressure, blood glucose control and blood fats.

Description:

This is a 6-month pilot intervention study which seeks to determine whether adherence to an intensive evidence based dietary programme, in addition to the prescription of both cardioprotective and hypoglycaemic medications recommended for patients with diabetes, will provide health benefits in terms of reducing the risk of developing or progression of complications of diabetes (particularly cardiovascular disease).

The specific aim of the project is to compare the effects of an intensive lifestyle intervention (based on the recently published evidence based recommendations of the Nutrition Study Group of the European Association for the Study of Diabetes [3]) or usual dietary advice, in diabetic patients at high risk of cardiovascular disease, treated with cardioprotective and hypoglycaemic drugs.

Study participants will be randomised into two groups:

• The control group will receive usual dietary advice and diabetes treatment from their usual GP and practice nurse (as detailed in the Management of Type 2 Diabetes and The Assessment and Management of Cardiovascular Risk guidelines published in December 2003 [1,2]).

• In addition to usual care, the intervention group will receive intensive instruction about a recommended dietary pattern based on the recently published recommendations of the Nutrition Study Group of the European Association for the Study of Diabetes [3] and where appropriate use material, for example serving size information from the above mentioned guidelines.

Outcome will be determined by examining surrogate markers of clinical endpoints. These surrogate markers will include clinical measures (weight, body mass index, blood pressure) and appropriate tests (haemoglobin A1c, fasting insulin, blood lipids, lipoproteins, inflammatory markers, and urine albumin creatinine ratio). A quality of life questionnaire will also be administered at the beginning and end of the project.

1. New Zealand Guidelines Group. The assessment and management of cardiovascular risk. Wellington, NZ. December, 2003. http://www.nzgg.org.nz

2. New Zealand Guidelines Group. Management of Type 2 diabetes. Wellington, NZ. December, 2003. http://www.nzgg.org.nz

3. Mann JI, De Leeuw I, Hermansen K, Karamanos B, Karlstrom B, Katsilambros N, Riccardi G, Rivellese AA, Rizkalla S, Slama G, Toeller M, Uusitupa M, Vessby B. Nutr Metab Cardiovasc Dis 14:373-394, 2004

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 70 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes

• Resident in Dunedin

• Aged <70 years at the time of invitation to participate

• Most recent HbA1c level within the last 12 months = 7%

• Currently prescribed oral tablets or insulin or both for glycaemic control AND three of the following: *Any pre-existing cardiovascular disease defined as a past history of myocardial infarction, angina, peripheral vascular disease, cerebrovascular accident, transient ischaemic attack; *Currently prescribed antihypertensive medication; *Currently prescribed lipid modifying medication; *Body mass index =25

Exclusion criteria:

• Terminal illness

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Intensive dietary advice

Locations

Country	Name	City	State
New Zealand	Edgar National Centre for Diabetes Research	Dunedin	Otago

Sponsors (2)

Lead Sponsor	Collaborator
Edgar National Centre for Diabetes Research	University of Otago

Country where clinical trial is conducted

New Zealand, 

References & Publications (3)

Mann JI, De Leeuw I, Hermansen K, Karamanos B, Karlström B, Katsilambros N, Riccardi G, Rivellese AA, Rizkalla S, Slama G, Toeller M, Uusitupa M, Vessby B; Diabetes and Nutrition Study Group (DNSG) of the European Association. Evidence-based nutritional approaches to the treatment and prevention of diabetes mellitus. Nutr Metab Cardiovasc Dis. 2004 Dec;14(6):373-94. — View Citation

New Zealand Guidelines Group. Assessment and Management of Cardiovascular Risk. December, 2003. Wellington, NZ. http://www.nzgg.org.nz. ISBN (print) 0-476-00091-2

New Zealand Guidelines Group. Management of Type 2 Diabetes. Wellington, NZ. December, 2003. http://www.nzgg.org.nz. ISBN (print): 0-476-00092-0

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index (BMI)
Primary	Glycated Haemoglobin (HbA1c)
Primary	Triglycerides
Primary	Dietary intake as measured by 3-day weighed diet records
Primary	All measures to be compared at end of study (6 months)
Secondary	Blood pressure
Secondary	Weight
Secondary	Waist circumference
Secondary	Total cholesterol and lipid subfractions (LDL, HDL)
Secondary	Fasting insulin
Secondary	Lipoproteins A + B
Secondary	Inflammatory markers
Secondary	Urinary albumin:creatinine ratio
Secondary	Quality of life
Secondary	All measures to be compared at end of study (6 months)

External Links

•   Edgar National Centre for Diabetes Research website