Liquid Total Diet Replacement (TDR) provided approximately 830 kcal / day with automatic reductions in all nutrients to induce rapid weight loss over 12 to 20 weeks. Antihypertensive drugs were withdrawn at the start of the regimen and BP was monitored regularly. The reintroduction of treatment was based on clinical guidelines.
Participants were randomized to an intervention or control group and all had been diagnosed with T2DM within the past 6 years. Other inclusion criteria included a glycated hemoglobin level of ≥ 6.5%, or ≥ 6.1% if on T2DM treatment, aged 18 to 65, and a body mass index (BMI) of 27 to 45 kg / m2.
Of 143 participants, 62 did not have hypertension and 81 did; of these 81 patients, 78 were taking antihypertensive drugs.
Of the 78, most stopped taking their medication completely at the start of the regimen, and 9 did not.
The overall mean BP decreased significantly from the start of the RDT and was significantly lower when the total diet replacement of the RDT ended at week 20. It remained below 12 and 24 months.
Of the 78 participants previously on treatment for hypertension, 65 (83%) stopped all antihypertensive and diuretic drugs according to protocol, and 4 stopped certain drugs.
These 69 participants saw no immediate BP change, but their average BP dropped significantly from 9 weeks onwards. While BP did not increase excessively, antihypertensive drugs were reintroduced during RDT to manage the increase in BP for 27.5% of the participants, even though they lost weight.
Participants who took 2 medications, as opposed to 1, were more likely to need to reintroduce their BP therapies.
At 24 months, 28% of those who stopped their antihypertensive therapy did not take any.
Of the 53 participants who achieved remission from T2DM through diet, 31 had previously been treated for hypertension.
The researchers said that although the protocol was safe and effective, careful monitoring of BP is necessary; 51 participants reported mild to moderate dizziness during RDT, suggesting orthostatic hypotension. Of these participants, 15 had a history of dizziness before starting the diet.
The study was carried out by researchers from the universities of Glasgow and Newcastle.
“We wanted to assess the safety and effectiveness of withdrawing hypertension medication at the start of our weight loss program designed specifically for type 2 diabetes, and we are really happy with the results,” Mike Lean, MD , MA, MB, FRCPS, FRSE, University of Glasgow Principal Clinical Investigator said in a press release. “Our study shows that in addition to possible remission of type 2 diabetes, there are other very important health benefits, as weight loss is a very effective treatment for hypertension and the serious risks for it. health associated with it. “
Leslie WS, Ali E, Harris L. et al. Antihypertensive Drug Needs and Blood Pressure Control with Weight Loss in the Diabetes Remission Clinical Trial (DiRECT). Diabetology. Published online May 31, 2021. doi: 10.1007 / s00125-021-05471-x