TOPIC: Treating Diabetics with diet and lifestyle changes vs. Medication regimen
Complete chart to defect article
Name:
Date:
NUR 787
Author, Year, Title, and Source | Design and General Quality | Sample Size and participation | Interventions | Outcomes | Level of Evidence | Findings |
Johansen, M. Y., MacDonald, C. S., Hansen, K. B., Karstoft, K., Christensen, R., Pedersen, M., Hansen, L. S., Zacho, M., Wedell-Neergaard, A. S., Nielsen, S. T., Iepsen, U. W., Langberg, H., Vaag, A. A., Pedersen, B. K., & Ried-Larsen, M. (2017). Effect of an intensive lifestyle intervention on glycemic control in patients with type 2 diabetes: A randomized clinical trial. JAMA, 318(7), 637–646. https://doi.org/10.1001/jama.2017.10169.
|
Design: A single-center, assessor-blinded, randomized clinical trial involving ninety-eight adult participants with non–insulin-dependent type 2 diabetes who were diagnosed for less than 10 years. The study was conducted within Region Zealand and the Capital Region of Denmark between April 2015 and August 2016. The participants were randomly assigned to the lifestyle/intervention and the standard care groups at the ratio of 2:1; stratified by sex. The lifestyle group had 64 participants and the standard care group had 34 participants.
Selection bias: The researchers only used subjects with type 2 diabetes diagnosed for less than 10 years. Patients diagnosed with type 2 diabetes for more than 10 years were excluded from the study.
Attrition: 2 patients from the intervention/lifestyle group were lost to follow-up at 3 months; from the standard care group, 2 patients were lost to follow-up at 3 months and another 1 patient was lost to follow-up at 9 months.
Performance bias: Blinding was done to all the test personnel, a factor that reduced the possibility of performance bias. |
N=98 adult patients with non-insulin-dependent type 2 diabetes who were diagnosed for less than 10 years before the time of the study.
Participants were recruited via media and the Danish Diabetes Association and screened through telephone interview and medical examination.
Inclusion criteria: Type 2 diabetes diagnosed less than 10 years, body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 25 to 40, and taking 2 or fewer glucose-lowering medications.
Exclusion criteria: HbA1c level greater than 9%, insulin-dependence, or presence of 1 or more of the following complications: diabetic retinopathy, macroalbuminuria (urine albumin-creatinine ratio ≥300 mg/g) or nephropathy (plasma creatinine ≥1.47 mg/dL [to convert to μmol/L, multiply by 88.4]). |
The aim of the study was to test whether an intensive lifestyle intervention results in equivalent glycemic control compared with standard care and, secondarily, leads to a reduction in glucose-lowering medication in participants with type 2 diabetes.
All participants were exposed to standard care with individual counseling and standardized, blinded, target-driven medical therapy. Additionally, the lifestyle group was subjected to 5 to 6 weekly aerobic training sessions (duration 30-60 minutes), of which 2 to 3 sessions were combined with resistance training. The lifestyle participants also received dietary plans aiming for a body mass index of 25 or less. Participants were followed up for 12 months. |
Primary outcome: Change in HbA1c level from baseline to 12-month follow-up.
Secondary outcome: Reduction in glucose-lowering medication from baseline to 12-month follow-up.
Exploratory outcomes: Changes from baseline to 12-month follow-up in total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, systolic and diastolic blood pressure, fasting insulin, fasting glucose, 2-hour glucose concentration following an oral glucose tolerance test, maximal oxygen uptake (V˙ O2max), weight, BMI, fat mass (total and abdominal), and lean body mass.
From baseline to 12-month follow-up, the mean HbA1c level changed from 6.65% to 6.34% in the lifestyle group and from 6.74% to 6.66% in the standard care group not meeting the criteria for equivalence (P = .15).
Reduction in glucose-lowering medications occurred in 47 participants (73.5%) in the lifestyle group and 9 participants (26.4%) in the standard care group. |
Level 1: RCT | A lifestyle intervention compared with standard care resulted in a change in glycemic control that did not reach the criterion for equivalence among adults with type 2 diabetes. However, the criterion was in a direction consistent with benefit. There is a need for further research to assess superiority, as well as generalizability and durability of findings. |
Reference
Johansen, M. Y., MacDonald, C. S., Hansen, K. B., Karstoft, K., Christensen, R., Pedersen, M., Hansen, L. S., Zacho, M., Wedell-Neergaard, A. S., Nielsen, S. T., Iepsen, U. W., Langberg, H., Vaag, A. A., Pedersen, B. K., & Ried-Larsen, M. (2017). Effect of an intensive lifestyle intervention on glycemic control in patients with type 2 diabetes: A randomized clinical trial. JAMA, 318(7), 637–646. https://doi.org/10.1001/jama.2017.10169.