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Type 2 Diabetes MellitusNCT00124553

LOADD (Lifestyle Over and Above Drugs in Diabetes) Study

A study testing Intensive dietary advice in people with Type 2 Diabetes Mellitus, run by Edgar National Centre for Diabetes Research at 1 site in New Zealand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages Up to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Intensive dietary advice
How many people
220 participants
Where
1 siteNew Zealand
Study dates
Aug 2006to Jun 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Terminal illness

Trial locations and contacts

1 site in 1 country.

Chris S Booker, BSc(Hons) contact

64-3-474-7775

chris.booker@stonebow.otago.ac.nz

Kirsten Coppell, FAFPHM contact

64-3-474-7774

kirsten.coppell@stonebow.otago.ac.nz

New Zealand1 site, 1 recruiting

  • Edgar National Centre for Diabetes Research

    Dunedin, Otago, 9001

    Chris S Booker, BSc(Hons), 64-3-474-7775, chris.booker@stonebow.otago.ac.nz

    Kirsten Coppell, FAFPHM, 64-3-474-7774, kirsten.coppell@stonebow.otago.ac.nz

    Recruiting

Other trials in New Zealand

About this 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

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.

Read the 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
Being tested
Intensive dietary advice
Keywords
Type 2 diabetes, cardiovascular risk, glycaemic control, dietary modification
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive dietary adviceBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body mass index (BMI)

  2. Glycated Haemoglobin (HbA1c)

  3. Triglycerides

  4. Dietary intake as measured by 3-day weighed diet records

  5. All measures to be compared at end of study (6 months)

Secondary outcomes (10)

  1. Blood pressure

  2. Weight

  3. Waist circumference

  4. Total cholesterol and lipid subfractions (LDL, HDL)

  5. Fasting insulin

  6. Lipoproteins A + B

  7. Inflammatory markers

  8. Urinary albumin:creatinine ratio

  9. Quality of life

  10. All measures to be compared at end of study (6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2005 (estimated)
  2. Study startAug 2006
  3. Study completionJun 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00124553
Sponsor's protocol ID
ENCDR_1
Status last verified
Mar 2007
First submitted
27 Jul 2005
Last updated
28 Mar 2007
Results posted
No

Publications

  • 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.

    PubMed 15853122

  • 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

  • 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.

    PubMed 20647285

Questions about this trial

What is this clinical trial studying?

A study testing Intensive dietary advice in people with Type 2 Diabetes Mellitus, run by Edgar National Centre for Diabetes Research at 1 site in New Zealand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chris S Booker, BSc(Hons) (64-3-474-7775, chris.booker@stonebow.otago.ac.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body mass index (BMI). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00124553, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2007.

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