An intensive lifestyle intervention can improve glycated hemoglobin (A1c) only slightly but dramatically reduces the need for diabetes medications in type 2 diabetes mellitus (T2DM) patients with good glucose control, according to a new study.
At the end of 1 year, mean A1c in the lifestyle group dropped from 6.65% at baseline to 6.34%. In the standard care group, A1c dropped from 6.74% to 6.66%. This result did not meet the pre-specified criteria for equivalence, reported researchers led by Mathias Ried-Larsen, PhD, of Rigshospitalet in Copenhagen, Denmark.
But about three-quarters (73%) of the lifestyle group reduced their glucose-lowering medications as compared with one-quarter (26%) of the standard care group.
The researchers published their results in August 15, 2017 Journal of the American Medical Association.
Currently, it is unclear whether a lifestyle intervention can maintain glycemic control in patients with T2DM. The researchers set out to determine whether an intensive lifestyle intervention can lead to glycemic control comparable with standard care in patients with T2DM.
The randomized, single-center, 1-year clinical trial included 98 participants, mean age 54.6 years, with non-insulin dependent T2DM. Their disease duration was less than 10 years. About half (48%) were women.
The patients were randomized 2:1, stratified by sex, to either the lifestyle intervention (64 patients) or the standard care group (34 patients). The treatment target for glycemic control was an A1c of 6.5%.
They were treated to a target of 6.5% with a standardized, algorithm-based regimen prior to the study so that the researchers could assess any additional effects of exercise. Mean A1c was 6.7% in all study participants at baseline.
The primary outcome was change in A1c from baseline, and the secondary outcome was reduction in glucose-lowering medications.
All of the patients received medical counseling, education, and lifestyle advice at baseline and every 3 months for 1 year. The study endocrinologist, who regulated all glucose-lowering, lipid-lowering, and blood pressure-lowering medication, followed pre-specified treatment targets and algorithms for glucose, lipid, and blood pressure.
The lifestyle participants additionally received 5 to 6 weekly group aerobic exercise sessions of 30-60 minutes; 2 of the 3 exercise sessions were combined with resistance training.
For the first 4 months, all exercise sessions were supervised; supervision was progressively reduced throughout the study. Participants were asked to eat an individual dietary plan with a macronutrient distribution of 45%-60% carbohydrates, 15%-20% proteins, and 20%-35% fats. During the first 4 months of the study, total energy intake was restricted.
One of the study’s limitation, the researchers stated, was that they only included non-insulin dependent patients with a disease duration of less than 10 years, and therefore the results might not be generalizable to other T2DM patients.
“A lifestyle intervention compared with standard care resulted in a change in glycemic control that did not reach the criterion for equivalence, but was in a direction consistent with benefit. Further research is needed to assess superiority, as well as generalizability and durability of findings,” the researchers concluded.
Source: Johansen MY, MacDonald CS, Hansen KB, et al. Effect of an intensive lifestyle intervension on glycemic control in patients with type 2 diabetes. JAMA. 2017; 318: 637 DOI: 10.1001/jama.2017.10169
Photo credit: ©Robert Kneschke/Shutterstock.com