Weight loss with different types of fasting in patients with type two diabetes and hypertension: a randomized clinical trial
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Background
The coexistence of type two diabetes (T2D) and cardiovascular diseases (CVD) in patients with overweight increases the risk of macro-vascular complications. Some studies are controversial of the results of Ramadan fasting (RF) in patients T2D+CVD.
Objective
To compare different RF (antique and modern) on anthropometric, glycemic, blood pressure (BP), lipids, heel bone mineral density (HBMD), and ejection fraction (EF) in patients with T2D+CVD.
Methods
An open, 60-day, controlled, single-center, randomized clinical trial included 51 patients (29 women) with T2D+CVD: 26 in Main (antique RF); 25 in Controls (modern RF). Primary endpoints: weight loss, fasting blood glucose and, blood insulin, BP. Secondary endpoints: blood lipids, HBMD, and EF.
Results
Patients in Main lost weight –8.02 kg ( P <0.0001), in Controls lost weight –2.67 kg ( P <0.025); BMI in Main significantly decreased ( P <0.0001), but in Controls did not significantly decrease ( P> 0.025). During a 30-day follow-up, Main did not regain weight and WC; but Controls regained weight and WC.
In Main BP, all glycemic parameters (fasting glucose, immunoassay insulin, HOMA-IR), lipids (cholesterol, triglyceride, HDL), HBMD, and EF in patients with and without heart failure (HF) were significantly normalized at 30-day RF ( P <0.0001). In Controls BP and all glycemic parameters significantly improved but they did not achieve normal ( P >0.025). In Controls HBMD and EF in patients with HF did not change ( P >0.025). At 30-day follow-up, glycemic, BP, lipids, HBMD, and EF parameters did not significantly change in Main; but in Controls they worsened as weight regained.
Conclusion
Both the RF methods allowed weight loss, but antique RF led to markedly weight loss and significant positive change in glycemic, BP, lipids, bone mineralization, and EF in patients with T2D+CVD; the antique RF allowed patients to stop taking medications. The duration of the positive results depended on the maintenance of the achieved weight loss on RF.
Trial Registration
ClinicalTrials.gov NCT06410352 (05/08/2024): https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S000EG8K&selectaction=Edit&uid=U0006MBT&ts=139&cx=bhsvd1
