Achieving Diabetes Remission Through 1 Year of Intensive Lifestyle Modification

How does one year of intensive control compare to standard treatment in achieving diabetes remission?

Of the chronic illnesses that affect millions of patients, type 2 diabetes is seen as a largely reversible disease that can be managed through various nonpharmacologic and pharmacologic techniques, including gastric bypass, medications, and lifestyle modifications. Mathias Ried-Larsen, PhD. notes that past studies have been conducted on very low caloric diets; however, said studies did not prioritize increasing physical activity or at the very least, encourage the increase of physical activity. Pancreatic beta cell destruction may be reversed if the disease is halted in a rapid manner. Using intensive lifestyle modifications, a potential reduction of inflammatory pathways, an increase in glycemic control, and the reversal of pancreatic beta cell destruction may be achieved. Ried-Larsen references a past study that led to the discontinuation of greater than 50% of patients who participated in the study. Thus there is reason to investigate further on whether the inclusion of intensive lifestyle modifications could alter the progression of type 2 diabetes and potentially reverse certain damages that were done by the disease. 

Hundreds of millions of patients worldwide are affected by Diabetes Mellitus; the importance of finding the best care possible for such a large population of people cannot be overstated. The primary endpoint of this study is to compare two standards of therapy in a head to head manner to determine which therapy has the greatest efficacy. The two therapies are intensive exercise-based lifestyle interventions versus standard therapy one year after termination of the lifestyle interventions in participants with short-lasting type 2 diabetes.

This clinical trial consisted of 87 participants in the capital city of Denmark. This single center trial is an extension of a previous trial whose results were previously published. The patients were followed up 12 months after the end of the trial. Patients who were barred from participation included those with diabetes related complications and macro-albuminuria. Although the blinding of patients was not feasible, patients were still randomized into separate groups and were given individualized dietary plans based on their BMI’s. Outcomes to be measured by the researchers were glycemic control, BMI, and the partial or complete remission of type 2 diabetes that was affecting the patients.

The results of the clinical trial point towards a more than 4-fold increase in remission rates when comparing the U-TURN intervention and the standard of care for diabetes management (odds ratio [OR] 4.4, 95% confidence interval [CI] 0.8-21.4]; P = 0.08). In terms of glycemic control, it seemed that the interventions had no effect on the matter when comparing the two interventions. BMI, weight, and fat composition were calculated at the beginning of the trial for a limited number of participants. Those who participated did not observe a change in BMI, significant weight loss, or a decrease in fat mass. Only a small number of participants achieved 5-%10% weight loss. The p values provided for the secondary outcomes were wide ranging and were all short of being significant. Although the U-TURN intervention observed a 4-fold increase in remission rate, the statistic was insignificant. This does not mean, however, that the trials were a waste. It does suggest that future studies with larger sample sizes should be conducted allowing us to confirm or deny the outcomes that the researchers found.

Practice Pearls:

• Although the findings of the trial were statistically insignificant, the findings of the trial should not be discounted.
• Future trials with larger sample sizes must be done to confirm or deny the findings of the trial.
• The findings of the trial showed a 4-fold increase in remission rate in patients with T2DM.

Reference for “Achieving Diabetes Remission Through 1 Year of Intensive Lifestyle Modification”:

Ried‐Larsen, Mathias, et al. “Type 2 Diabetes Remission One Year after an Intensive Lifestyle Intervention: A Secondary Analysis of a Randomized Clinical Trial.” Diabetes, Obesity and Metabolism, 5 June 2019, doi:10.1111/dom.13802.

Usif Darwish, PharmD Candidate, Florida A&M University, College of Pharmacy & Pharmaceutical Sciences