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

Kirsten J Coppell, Minako Kataoka, Sheila M Williams, Alex W Chisholm, Sue M Vorgers, Jim I Mann, Kirsten J Coppell, Minako Kataoka, Sheila M Williams, Alex W Chisholm, Sue M Vorgers, Jim I Mann

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 (HbA(1c)) 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: HbA(1c) 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 HbA(1c) 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 HbA(1c) despite optimised hypoglycaemic drug treatment.

Trial registration: Clinical trials NCT00124553.

Conflict of interest statement

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.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4787708/bin/copk750059.f1_default.jpg
Flow chart of participants.

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Source: PubMed

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