The DiRECT trial reported some exciting findings  in  "The Lancet" that could revolutionise the way type 2 diabetes is treated.

A recent clinical study published in the December 2017 edition of "The Lancet "has achieved a major goal in treating Type 2 Diabetes Mellitus (T2DM). The DiRECT (Diabetes Remission Clinical Trial) intervention study on Total Diet Replacement (TDR) and weight loss programs is revolutionising the assumption made by the scientists pertaining to diabetes as a life-long condition.The results of this trial were presented at the International Diabetes Federation Congress (IDFC), held in Abu Dhabi in Dec 2017. The main highlights are summarized below.

DiRECT Trial procedure

An open-label randomized trial conducted at 49 primary care practices was funded by Diabetes UK and the formula diet was donated by Cambridge Weight Plan (CWP). The study was carried out in the most realistic prospect, under the supervision of dieticians and nurses, trained for 8 hours, to allow maximal transferability into routine healthcare. The participants included men and women, aged 20 to 65, with chronic T2DM condition, and Body Mass Index (BMI) of >27 kg/m² and <45 kg/m².

The interventions included Total Diet Replacement (TDR) phase followed by structured food reintroduction (FR), and weight loss management. The primary care physicians can adopt these interventions, as they are easy to execute.

Total Diet Replacement (TDR) phase

The TDR phase necessitated the replacement of usual food with commercial micronutrient-replete 825 to 853 kcal/day liquid formula diet (CWP) such as health drinks and soups for 12 weeks. On commencement of TDR, T2DM or hypertension drugs such as Oral hypoglycaemic agents (OHA), antihypertensive and diuretic drugs were withdrawn and reintroduced if the conditions returned. Patients with previous MI were allowed to continue aspirin. Beta-blockers prescribed for angina were continued and soluble fibre supplement (Fybogel 2 × 3.5 g/day) was prescribed for treating constipation. If the BMI was < 23 kg/m², FR phase was introduced.

Food Reintroduction (FR) Phase

The FR phase included food-based diet from 12 to 18 weeks post the TDR phase. Post switching to full food-based weight loss maintenance, the weight was monitored on a weekly basis and compared with calorie intake and physical activity levels.

Weight Loss & Weight Loss Maintenance Phase

After the TDR and FR phase, and increase in physical activities, 90% of participants with chronic T2DM showed weight loss up to 5 kg in the first 3 months and gradually lost up to 15 kg, which normalized their blood glucose level. The serum triglycerides levels were reduced to 20% (95% CI 11–28). Magnetic Resonance (MR) studies of pancreatic and hepatic fat showed improved functioning of pancreas and improved production of insulin (by separate calculation of intra-organ fat content and β-cell function in a subgroup of the DiRECT cohort).

Key Takeaways

Diabetes mellitus is reversible

Diabetes mellitus, as contrary to the widespread notion of a life-long disease, can be reversed. The non-surgical randomised approach to dietary and lifestyle intervention can provide personal and health-service-related benefits such as improved quality of life and elimination of T2DM. By following the same protocol as in the study, patients with chronic T2DM can become non-diabetic, more fit, energetic and may no longer need diabetic medication.

Structured weight loss program with dietary interventions offer health benefits

Intensive evidence-based program on structured weight management provides high benefits for a decrease in the weight up to 15 kg (33 lb) and increase in the glycated hemoglobin up to 48 mmol/mol in 90% of the patients and 10 kg (22 lb) in the remaining patients, normalizing their blood glucose level. The associated elevated risks of cardiovascular diseases are reduced with 21% decrease in the occurrence of the outcomes.

Structured weight loss program with dietary interventions is better than surgery

Bariatric surgery is considered as one of the options for weight loss and disease management in diabetes. However, the structured weight loss and diet management program is a better option than bariatric surgery for weight loss. The program is cost-effective with no risk of long-term problems.

Co-morbid conditions may also need attention

About 50% of the diabetic patients are known to have arthritis. Physicians must prescribe pain medication and treat the condition, prior to initiating the therapy. Physicians must review the past medical history of the patient thoroughly to check the eligibility before concentrating on this therapy.

The DiRECT study may prove to be a turning point in diabetes management. With an active support from the primary care physicians, the patients can now hope for a disease-free future. The physicians need to take an initiative to educate their patients that diabetes can be indeed reversed if the patients take active participation in disease management.