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DIADEM-I: intensive lifestyle intervention can reverse T2DM

Fri, 06/26/2020 - 08:51
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Type 2 diabetes can be reversed in more than 60% of participants through dietary change, physical activity and behaviour change, and without medication or bariatric surgery, according to a team of researchers from Qatar. These were the conclusions from the DIADEM-I clinical trial, thought to be the first intensive lifestyle intervention trial in the Middle East and North Africa region and is the country’s first clinical trial in primary care.

The study was led by teams at Hamad Medical Corporation’s (HMC) Qatar Metabolic Institute (QMI), Primary Health Care Corporation (PHCC), Qatar Diabetes Association (QDA) and Weill Cornell Medicine-Qatar (WCM-Q), was funded by the Qatar National Research Fund (QNRF). The outcomes were reported in the paper, ‘Effect of intensive lifestyle intervention on bodyweight and glycaemia in early type 2 diabetes (DIADEM-I): an open-label, parallel-group, randomised controlled trial’, and published in The Lancet Diabetes and Endocrinology.

"This study proves that it is possible to reverse diabetes through lifestyle modification and that this course of treatment results in a better outcome than diabetes medications or bariatric surgery,” added Dr Shahrad Taheri, Senior Consultant at HMC, Chair of the QMI Research Committee and a Professor at WCM-Q, and the lead principal investigator of the study. “The research study was a success because of a close partnership between HMC-QMI, PHCC, QDA, and WCM-Q. We are now going to take the findings from the research into the clinic. The planned clinics and future research will benefit from state-of-the-art facilities, including wellness centres in primary care.”

The DIADEM-I clinical study was designed to assess whether an intensive lifestyle intervention would lead to significant weight loss and improved glycaemia in young individuals with early diabetes, compared the effects of an intensive lifestyle intervention with usual medical care on weight loss and glycaemic outcomes in individuals with T2DM, aged 18–50 years, with a short diabetes duration (≤3 years), with a BMI>27 and who were from the Middle East and north Africa region. Participants were randomly allocated (1:1) either to the intensive lifestyle intervention group or the usual medical care control group by a computer-generated sequence and an online randomisation service.

The intensive lifestyle intervention comprised a total diet replacement phase, in which participants were given formula low-energy diet meal replacement products followed by gradual food reintroduction combined with physical activity support, and a weight-loss maintenance phase, involving structured lifestyle support. Participants in the control group received usual diabetes care, which was based on clinical guidelines. The primary outcome was weight loss at 12 months after receiving the assigned intervention (analysis was based on the intention-to-treat principle) and the key secondary outcomes included diabetes control and remission.

"The research targeted patients who developed Type 2 diabetes within the past two years. One group of study participants received optimal diabetes care with diabetes medications, education, and dietary consultation. The other group received meal replacement for three months targeting weight reduction, followed by a weight maintenance regular diet,” said Professor Abdul-Badi Abou-Samra, Director, Qatar Metabolic Institute (QMI), and one of the study’s principal investigators. They received no diabetes medication at all.

Outcomes

From July to and September 2018, 158 participants were enrolled and randomly assigned (n=79 in each group) to each group and 147 participants (70 in the intervention group and 77 in the control group) were included in the final intention-to-treat analysis population.

Between baseline and 12 months, the mean bodyweight of participants in the intervention group reduced by 11.98kg (95% CI 9·72 to 14·23), compared with 3.98 kg (2·78 to 5·18) in the control group (adjusted mean difference −6.08 kg, p<0·0001). In the intervention group, 21% of participants achieved more than 15% weight loss between baseline and 12 months, compared with 1% of participants in the control group (p<0·0001). Diabetes remission occurred in 61% of participants in the intervention group compared with 12% of those in the control group (odds ratio [OR] 12.03 [95% CI 5·17 to 28·03], p<0·0001).

In total, 33% of participants in the intervention group had normo-glycaemia, compared with 4% of participants in the control group (OR 12·07 [3.43 to 42.45], p<0·0001). Five serious adverse events were reported in four participants in the control group; four admissions to hospital because of unanticipated events (supraventricular tachycardia, abdominal pain, pneumonia, and epididymo-orchitis), and one admission to hospital for an anticipated event (hyperglycaemia).

“Our findings show that the intensive lifestyle intervention led to significant weight loss at 12 months and was associated with diabetes remission in over 60% of participants and normo-glycaemia in over 30% of participants,” the authors concluded. “The provision of this lifestyle intervention could allow a large proportion of young individuals with early diabetes to achieve improvements in key cardiometabolic outcomes, with potential long-term benefits for health and wellbeing.”

"The results of the study are important because they will have a significant, positive impact on the lives of people affected by Type 2 diabetes,” said Dr Samya Al Abdulla, Senior Consultant and Executive Director of Operations at PHCC, and a principal investigator of the study. “As the majority of Type 2 diabetic patients are cared for in the primary care setting, PHCC fully supports this collaborative initiative which we know will help benefit our patients and reduce the health burden of diabetes in the community.”

"As an integral part of the Qatar National Diabetes Strategy, diabetic research such as this study enhance our understanding of not only the disease, but also therapeutic interventions. Research that focuses on the local population is instrumental in developing effective and specialized treatments for people with Type 2 diabetes, both in Qatar and region," said Dr Abdullah Al Hamaq, Executive Director of the Qatar Diabetes Association (QDA), a member of Qatar Foundation (QF), and a principal investigator of the study.

Professor Abou-Samra added that the research is highly relevant to Qatar because Type 2 diabetes is prevalent in the country and the findings provide treating physicians with evidence that supports an effective, alternative method for disease management.

"These findings are evidence that Type 2 diabetes does not have to be a progressive and irreversible disease. It is a treatable disease when an effective lifestyle intervention is used, particularly in patients with recent diabetes development. Through lifestyle intervention, there can be no progression of the disease and no progression of complications, and that is very significant for current and future generations. In the coming months we are planning to open a Diabetes Reversal Clinics for patients who are motivated to treat their diabetes through lifestyle modification.”