Beta Cell Restoration Through Fat Mitigation

Obesity is one of the key risk factors in the development of type 2 diabetes. Research has shown that excess body mass is linked to insulin resistance and loss of beta-cell function, which are precursors of type 2 diabetes. Clinical studies indicate medication and weight loss attained through lifestyle changes are both effective at slowing the progression of the disease by mitigating the effects of obesity on beta-cell function. The Beta Cell Restoration Through Fat Mitigation (BetaFat) Study was created to determine if weight loss through gastric banding surgery would be more effective than metformin medication at sustaining or improving beta-cell function in individuals with prediabetes or early type 2 diabetes, who are also mildly to moderately obese.

BetaFat, a component of the Restoring Insulin Secretion (RISE) Consortium, was a two-arm, unblinded clinical trial. Study participants were recruited at the University of Southern California and randomized into two intervention groups. One group received gastric banding surgery and the other group was treated with metformin. Patients underwent assessments at baseline and at predetermined intervals during the 24-month study period. Beta-cell function, insulin sensitivity, and blood glucose levels were regularly evaluated during the study period. Participants were also monitored for adverse effects to the interventions.

肥胖是2型糖尿病发生的关键危险因素之一。已有研究证实，体质量过剩与胰岛素抵抗（insulin resistance）及β细胞功能（beta-cell function）丧失密切相关，而二者均为2型糖尿病的前驱病理状态。临床研究表明，药物治疗与通过生活方式干预实现的体重减轻，均可通过减轻肥胖对β细胞功能的不良影响，有效延缓疾病进展。本研究「通过减轻脂肪负荷恢复β细胞功能（BetaFat）研究」旨在探究：对于合并轻度至中度肥胖的糖尿病前期或早期2型糖尿病患者，与二甲双胍（metformin）药物治疗相比，通过胃束带手术实现的体重减轻能否更有效地维持或改善β细胞功能。

BetaFat作为恢复胰岛素分泌（Restoring Insulin Secretion, RISE）联盟的子研究项目，为一项双臂非盲临床试验。研究受试者于南加州大学招募，并被随机分配至两个干预组：一组接受胃束带手术，另一组接受二甲双胍治疗。受试者在研究基线及24个月研究周期内的预设随访时间点接受系统评估。研究期间定期检测β细胞功能、胰岛素敏感性及血糖水平，同时持续监测受试者对干预措施的不良反应。