The Effect of Exercise and Nicotinamide Riboside on Muscle Health and Insulin Resistance in Adult Survivors of Childhood Cancer With Prediabetes: A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility of a nutrition and exercise program in childhood cancer survivors (CCS)
研究概览
简要总结
This trial studies the effect of exercise and nicotinamide riboside on muscle health and insulin resistance in adult survivors of childhood cancer with prediabetes (elevated blood sugar level that is not high enough to be considered diabetes). Nicotinamide riboside is a dietary supplement which is similar to vitamin B3. Information collected in this study may help the future development of regimens to improve metabolic outcomes such as muscle health and insulin resistance (when the body is not normally responding to insulin) in childhood cancer survivors.
详细描述
PRIMARY OBJECTIVE:
I. Evaluate the feasibility of conducting a home exercise and nutrition intervention in childhood cancer survivors (CCS) with a history of prediabetes.
EXPLORATORY OBJECTIVES:
I. Describe the association between patient demographics and treatment exposures and subsequent hyperglycemia and skeletal muscle health in childhood cancer survivors.
II. Describe the effect of exercise with or without nicotinamide riboside (NR) on hyperglycemia and skeletal muscle health in CCS with a history of prediabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of childhood cancer
- •History of prediabetes (HbA1c 5.7-6.4%)
- •In remission at time of enrollment
- •Time between completion of cancer-directed therapy and study entry: >= 6 months
- •At least 18 years of age at time of enrollment
- •Able to access online exercise program at home
- •Ability to tolerate the prescribed resistance exercise program
- •English-speaking
- •Able to understand and sign the study specific informed consent form (ICF)
排除标准
- •Taking a nicotinamide adenine dinucleotide (NAD)+ precursor in the two weeks prior to enrollment
- •Currently taking medication for hyperglycemia or diabetes
- •Females who are pregnant or planning to become pregnant
- •Currently recovering from an injury
- •Contraindication to magnetic resonance imaging (MRI)
- •Pacemaker
结局指标
主要结局
Feasibility of a nutrition and exercise program in childhood cancer survivors (CCS)
时间窗: Up to 6 weeks
The current protocol will be considered feasible if: 1. \>= 50% of eligible patients that are approached for participation enroll onto the study, 2. \>= 70% of enrolled participants successfully complete all study assessments (i.e. physical function tests, blood draw, imaging, and questionnaires at baseline and 6 weeks, and 3. Enrolled participants demonstrate \>= 70% compliance with prescribed exercise and nicotinamide riboside. Feasibility measures 2 and 3 will be assessed for the entire group of 20 subjects as a whole.
次要结局
未报告次要终点