Clinical trial NCT00124553: LOADD (Lifestyle Over and Above Drugs in Diabetes) Study
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes
cardiovascular risk
glycaemic control
dietary modification
Lead sponsor: Edgar National Centre for Diabetes Research
Sponsor class: OTHER
Collaborators: name: University of Otago
First posted: 2005-07-28
Enrollment: 220
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Body mass index (BMI)
measure: Glycated Haemoglobin (HbA1c)
measure: Triglycerides
measure: Dietary intake as measured by 3-day weighed diet records
measure: All measures to be compared at end of study (6 months)
Secondary outcomes:
measure: Blood pressure
measure: Weight
measure: Waist circumference
measure: Total cholesterol and lipid subfractions (LDL, HDL)
measure: Fasting insulin
measure: Lipoproteins A + B
measure: Inflammatory markers
measure: Urinary albumin:creatinine ratio
measure: Quality of life
measure: All measures to be compared at end of study (6 months)
Other outcomes:
Locations:
city: Dunedin
country: New Zealand
facility: Edgar National Centre for Diabetes Research
state: Otago
Study officials:
affiliation: Edgar National Centre for Diabetes Research
name: Jim I Mann, FRACP
role: PRINCIPAL_INVESTIGATOR
affiliation: Edgar National Centre for Diabetes Research
name: Kirsten Coppell, FAFPHM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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; 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. doi: 10.1016/s0939-4753(04)80028-0. No abstract available.
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
citation: New Zealand Guidelines Group. Management of Type 2 Diabetes. Wellington, NZ. December, 2003. http://www.nzgg.org.nz. ISBN (print): 0-476-00092-0
citation: Coppell KJ, Kataoka M, Williams SM, Chisholm AW, Vorgers SM, Mann JI. Nutritional intervention in patients with type 2 diabetes who are hyperglycaemic despite optimised drug treatment--Lifestyle Over and Above Drugs in Diabetes (LOADD) study: randomised controlled trial. BMJ. 2010 Jul 20;341:c3337. doi: 10.1136/bmj.c3337.