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; 341 doi: https://doi.org/10.1136/bmj.c3337 (Published 20 July 2010) Cite this as: BMJ 2010;341:c3337
- Kirsten J Coppell, senior research fellow1,
- Minako Kataoka, research dietitian2,
- Sheila M Williams, research associate professor3,
- Alex W Chisholm, senior lecturer nutrition2,
- Sue M Vorgers, research nurse2,
- Jim I Mann, professor of human nutrition and medicine1
- 1Edgar National Centre for Diabetes and Obesity Research, Department of Medical and Surgical Sciences, University of Otago, PO Box 913, Dunedin 9054, New Zealand
- 2Department of Human Nutrition, University of Otago
- 3Department of Preventive and Social Medicine, University of Otago
- Correspondence to: K Coppell kirsten.coppell{at}otago.ac.nz
- Accepted 19 May 2010
Abstract
Objective To determine the extent to which intensive dietary intervention can influence glycaemic control and risk factors for cardiovascular disease in patients with type 2 diabetes who are hyperglycaemic despite optimised drug treatment.
Design Randomised controlled trial.
Setting Dunedin, New Zealand.
Participants 93 participants aged less than 70 years with type 2 diabetes and a glycated haemoglobin (HbA1c) of more than 7% despite optimised drug treatments plus at least two of overweight or obesity, hypertension, and dyslipidaemia.
Intervention Intensive individualised dietary advice (according to the nutritional recommendations of the European Association for the Study of Diabetes) for six months; both the intervention and control participants continued with their usual medical surveillance.
Main outcome measures HbA1c was the primary outcome. Secondary outcomes included measures of adiposity, blood pressure, and lipid profile.
Results After adjustment for age, sex, and baseline measurements, the difference in HbA1c between the intervention and control groups at six months (−0.4%, 95% confidence interval −0.7% to −0.1%) was highly statistically significant (P=0.007), as were the decreases in weight (−1.3 kg, −2.4 to −0.1 kg; P=0.032), body mass index (−0.5, −0.9 to −0.1; P=0.026), and waist circumference (−1.6 cm, −2.7 to −0.5 cm; P=0.005). A decrease in saturated fat (−1.9% total energy, −3.3% to −0.6%; P=0.006) and an increase in protein (1.6% total energy, 0.04% to 3.1%; P=0.045) in the intervention group were the most striking differences in nutritional intake between the two groups.
Conclusions Intensive dietary advice has the potential to appreciably improve glycaemic control and anthropometric measures in patients with type 2 diabetes and unsatisfactory HbA1c despite optimised hypoglycaemic drug treatment.
Trial registration Clinical trials NCT00124553.
Footnotes
We thank all participants in the LOADD study; general practices, the Dunedin Hospital diabetes clinic and Otago Diabetic Eye Monitoring Service, and Diabetes Otago, who assisted with recruitment; Wendy Aitken, Claire Lamb, Michelle McGrath, Margaret Waldron, and Sharyn Willis for clinical and dietetic assistance; Chris Booker, Victoria Farmer, Margaret Johnston, and Megan Somerville for administrative assistance; Ashley Duncan and Michelle Harper from the Diabetes Laboratory of the Department of Human Nutrition, University of Otago, Southern Community Laboratory Dunedin and Diabetes New Zealand (www.diabetes.org.nz), who approved use of their diabetes dietary resources in the LOADD study.
Contributors: KJC and JIM conceived the study; contributed to the design, implementation, conduct, and monitoring of the study and analysis and interpretation of results; wrote most of the first draft; and were responsible for editing the manuscript. MK participated in the implementation and conduct of the study and contributed to the analysis, interpretation of the study, and editing the manuscript. SMW contributed to the design; did the analyses; and contributed to the interpretation of the study, writing the first draft, and editing the manuscript. AWC contributed to the design, implementation, conduct, and monitoring of the study; analysis and interpretation of results; and editing the manuscript. SMV participated in the implementation and conduct of the study and editing the manuscript. All authors approved the final draft of the manuscript. All authors had full access to all of the data. KJC and JIM are the guarantors.
Funding: This study was supported by grants from the Health Research Council of New Zealand (06/352) and the Southern Trust, New Zealand. The funders had no role in any aspect of the study.
Competing interests: All authors have completed the Unified Competing Interest form at http://www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: (1) No financial support for the submitted work from anyone other than their employer; (2) No financial relationships with commercial entities that might have an interest in the submitted work; (3) No spouses, partners, or children with relationships with commercial entities that might have an interest in the submitted work; (4) No non-financial interests that may be relevant to the submitted work.
Ethical approval: The Lower South Regional Ethics Committee approved this study (LRS/05/07/026), and participants gave written consent before the pre-randomisation clinical assessment.
Data sharing: No additional data available.
- Accepted 19 May 2010
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