The accelerated reduction Method of glycated haemoglobin in patients with type 2 diabetes mellitus and hypertension: a comparative clinical trial

Aim: to compare different weight-loss methods such as pharmacologic, bariatric surgery, and very-low-calorie diet (VLCD) in accelerated decline in HbA1c in patients with T2D and hypertension. Methods. Design: a 30-day open label, prospective, multicenter, comparative clinical trial including 102 adult patients with T2D and hypertension were divided in three groups: Drug group; Surgical group; and VLCD. Primary endpoints: HbA1c; body weight. Results. At 30 days, body weight in the patients decreased significantly in Surgery group (-10.5%; P =0.009) and in VLCD group (-12.2%; P =0.003), while in Drug group the decrease was unsignificant (-1.2%; P =0.39). In all comparison groups the decrease in body weight occurred due to both fat and lean mass. SBP in Drug group decreased by -6.5%, DBP decreased by -3.4%. SBP/DBP in Surgical group changed by -1.6% and -2.9%, respectively. SBP/DBP in VLCD group significantly decreased by -24.3% and 18.6% ( P <0.0001), respectively. Correlation-regression analysis revealed a correlation between weight loss and a decrease in HbA1c (r=0.53; P <0.0001). Conclusions. The fastest method to reduce HbA1c in patients with T2D and hypertension was in VLCD group. The greater the weight loss, the lower the HbA1c. The great reduction in HbA1c led to a decrease in symptomatic drugs up to its complete abolition. Trial Registration: ClinicalTrials.gov NCT06410352 (05/08/2024): https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S000EG8K&selectaction=Edit&uid=U0006MBT&ts=56&cx=-vph5l9