LOADD (Lifestyle Over and Above Drugs in Diabetes) Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Edgar National Centre for Diabetes Research.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Otago
Information provided by:
Edgar National Centre for Diabetes Research
ClinicalTrials.gov Identifier:
NCT00124553
First received: July 27, 2005
Last updated: March 27, 2007
Last verified: March 2007
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Behavioral: Intensive dietary advice

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

Resource links provided by NLM:


Further study details as provided by Edgar National Centre for Diabetes Research:

Primary Outcome Measures:
  • Body mass index (BMI)
  • Glycated Haemoglobin (HbA1c)
  • Triglycerides
  • Dietary intake as measured by 3-day weighed diet records
  • All measures to be compared at end of study (6 months)

Secondary Outcome Measures:
  • Blood pressure
  • Weight
  • Waist circumference
  • Total cholesterol and lipid subfractions (LDL, HDL)
  • Fasting insulin
  • Lipoproteins A + B
  • Inflammatory markers
  • Urinary albumin:creatinine ratio
  • Quality of life
  • All measures to be compared at end of study (6 months)

Estimated Enrollment: 220
Study Start Date: August 2006
Estimated Study Completion Date: June 2008
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

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124553

Contacts
Contact: Chris S Booker, BSc(Hons) 64-3-474-7775 chris.booker@stonebow.otago.ac.nz
Contact: Kirsten Coppell, FAFPHM 64-3-474-7774 kirsten.coppell@stonebow.otago.ac.nz

Locations
New Zealand
Edgar National Centre for Diabetes Research Recruiting
Dunedin, Otago, New Zealand, 9001
Contact: Chris S Booker, BSc(Hons)    64-3-474-7775    chris.booker@stonebow.otago.ac.nz   
Contact: Kirsten Coppell, FAFPHM    64-3-474-7774    kirsten.coppell@stonebow.otago.ac.nz   
Principal Investigator: Jim I Mann, FRACP         
Sponsors and Collaborators
Edgar National Centre for Diabetes Research
University of Otago
Investigators
Principal Investigator: Jim I Mann, FRACP Edgar National Centre for Diabetes Research
Principal Investigator: Kirsten Coppell, FAFPHM Edgar National Centre for Diabetes Research
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00124553     History of Changes
Other Study ID Numbers: ENCDR_1
Study First Received: July 27, 2005
Last Updated: March 27, 2007
Health Authority: New Zealand: Health and Disability Ethics Committees

Keywords provided by Edgar National Centre for Diabetes Research:
Type 2 diabetes
cardiovascular risk
glycaemic control
dietary modification

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014