NCT00124553

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2005

Completed
1 year until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

March 28, 2007

Status Verified

March 1, 2007

First QC Date

July 27, 2005

Last Update Submit

March 27, 2007

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetescardiovascular riskglycaemic controldietary modification

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (10)

  • Blood pressure

  • Weight

  • Waist circumference

  • Total cholesterol and lipid subfractions (LDL, HDL)

  • Fasting insulin

  • +5 more secondary outcomes

Interventions

Intensive dietary adviceBEHAVIORAL

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Terminal illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edgar National Centre for Diabetes Research

Dunedin, Otago, 9001, New Zealand

RECRUITING

Related Publications (4)

  • 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.

    PMID: 15853122BACKGROUND

  • 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

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 20647285DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jim I Mann, FRACP

    Edgar National Centre for Diabetes Research

    PRINCIPAL INVESTIGATOR

  • Kirsten Coppell, FAFPHM

    Edgar National Centre for Diabetes Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris S Booker, BSc(Hons)

CONTACT

64-3-474-7775chris.booker@stonebow.otago.ac.nz

Kirsten Coppell, FAFPHM

CONTACT

64-3-474-7774kirsten.coppell@stonebow.otago.ac.nz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 27, 2005

First Posted

July 28, 2005

Study Start

August 1, 2006

Study Completion

June 1, 2008

Last Updated

March 28, 2007

Record last verified: 2007-03

Locations

NZ(1)