Effects Of Combined Vitamin D Supplementation And Resistance Training On Sarcopenia And Glycemic Control in Type 2 Diabetes Mellitus: An Open-label Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 3. Change in physical performance (gait speed and chair stand test) from baseline to 12 weeks across four groups, with the combined intervention expected to show the greatest improvement.
研究概览
简要总结
Diabetes mellitus is a major public health challenge, with India contributing significantly to the global burden. Type Two Diabetes Mellitus is the most common form, linked to insulin resistance, aging, and obesity, and is often complicated by sarcopenia. Sarcopenia is characterized by a decline in skeletal muscle mass, strength, and physical performance, and is more prevalent in people with diabetes.
Vitamin D plays a key role in muscle health, and deficiency is associated with a higher risk of sarcopenia. Supplementation with Vitamin D at safe daily doses can improve muscle metabolism. Resistance training is an established strategy for improving muscle strength, functional capacity, and glycemic control.
While the benefits of Vitamin D supplementation and resistance training are individually supported, their combined effect in people with Type Two Diabetes Mellitus and sarcopenia is not well studied. This randomized controlled trial will evaluate whether daily oral Vitamin D supplementation with 2000 IU and thrice-weekly supervised resistance training for twelve weeks can improve skeletal muscle mass, strength, physical performance, and glycemic control compared to either intervention alone or control. The study aims to provide evidence for a feasible and affordable strategy to address sarcopenia in individuals with diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants must meet all of the following:
- •Diagnosis of Type Two Diabetes Mellitus (T2DM): HbA1c greater than or equal to six point five percent (IDF 2025).
- •Sarcopenia, defined by Asian Working Group for Sarcopenia (AWGS) 2019 criteria: a.
- •Low skeletal muscle mass (SMI less than seven point zero kilogram per meter square in men, less than five point seven kilogram per meter square in women).
- •And low muscle strength (handgrip less than twenty eight kilogram in men, less than eighteen kilogram in women).
- •Or low physical performance (gait speed less than zero point eight meter per second or chair stand greater than twelve seconds).
- •Age range: Forty to sixty years (targeting peak sarcopenia progression in T2DM).
- •Ambulatory status: Ability to perform functional tests and exercise interventions.
- •Women aged forty to sixty years with Type Two Diabetes Mellitus who are premenopausal, perimenopausal, or postmenopausal will be included, as estrogen decline during menopausal transition contributes to impaired muscle protein synthesis and mitochondrial dysfunction, increasing the risk and severity of sarcopenia in this population.
排除标准
- •Participants will be excluded for any of the following:
- •Diabetes subtype: Type One Diabetes Mellitus or secondary diabetes.
- •Renal impairment: Chronic kidney disease with estimated glomerular filtration rate less than thirty milliliter per minute per one point seven three meter square.
- •3.Comorbidities: Active malignancy, recent fractures within six months, or hospitalization within three months.
- •4.Pharmacological confounders: a.
- •Current vitamin D supplementation greater than one thousand International Units per day prior to study entry.
- •Use of anabolic steroids.
- •Use of statins.
- •5.Other exclusions: a.
- •Pregnancy or lactation.
- •Cognitive impairment or inability to provide informed consent.
- •Contraindications to exercise such as cardiovascular or musculoskeletal conditions.
结局指标
主要结局
3. Change in physical performance (gait speed and chair stand test) from baseline to 12 weeks across four groups, with the combined intervention expected to show the greatest improvement.
时间窗: Baseline and twelve weeks
1. Change in skeletal muscle index from baseline to 12 weeks across four groups, with the combined intervention expected to show the greatest improvement.
时间窗: Baseline and twelve weeks
2. Change in handgrip strength from baseline to 12 weeks across four groups, with the combined intervention expected to show the greatest improvement.
时间窗: Baseline and twelve weeks
次要结局
- 1. Change in Hemoglobin A1c from baseline to twelve weeks among the four groups, with the combined intervention group expected to show greater reduction compared to the Vitamin D only group, the Resistance Training only group & the Control group.(2. Change in insulin resistance from baseline to twelve weeks assessed by Homeostatic Model Assessment for Insulin Resistance among the four groups, with the combined intervention group expected to show greater improvement compared to the Vitamin D only group, the Resistance Training only group & the Control group.)
研究者
J Edward Arulswamy
SRM Medical College Hospital and Research Centre