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.
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.


METHODS
Randomised controlled trial.


METHODS
Dunedin, New Zealand.


METHODS
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.


METHODS
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.


METHODS
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.


BACKGROUND
Clinical trials NCT00124553.
Coppell
Kirsten J
KJ
Edgar National Centre for Diabetes and Obesity Research, Department of Medical and Surgical Sciences, University of Otago, PO Box 913, Dunedin 9054, New Zealand. kirsten.coppell@otago.ac.nz
Kataoka
Minako
M
Williams
Sheila M
SM
Chisholm
Alex W
AW
Vorgers
Sue M
SM
Mann
Jim I
JI
D050154:Adiposity / Q000502:physiology*; D001794:Blood Pressure / Q000502:physiology; D003924:Diabetes Mellitus, Type 2 / Q000178:diet therapy* / Q000188:drug therapy; D004351:Drug Resistance; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D006943:Hyperglycemia / Q000178:diet therapy* / Q000188:drug therapy; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008019:Life Style; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged
D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008055:Lipids