A Pilot Trial of the Effect of Dietary and Exercise Intervention on Insulin Resistance and Metabolic Parameters in De Novo Renal Transplant Recipients on Prograf (Tacrolimus)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 主要终点
- Percentage of Participants With Insulin Resistance
研究概览
简要总结
The purpose of this trial is to investigate whether a combined dietary and exercise intervention, added to standard care, reduces the expected frequency of insulin resistance in renal (kidney) transplant recipients on tacrolimus.
详细描述
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), single-arm, multi-center (conducted in more than 1 center), interventional pilot study of the effects of a combined dietary and exercise intervention on glucose metabolism. The duration of this study will be 6 months and will include following visits: Baseline, Week 4, Week 12, and Week 24. Dietary compliance will be evaluated with a 3-day food record and during weekly telephone conversations and face-to-face visits with a dietician. Exercise compliance will be measured using an exercise log presented to the co-ordinator at the end of each month. Primarily, participants with insulin resistance will be assessed by Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) of greater than 1 at 6 months. Participants' safety and tolerability will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Participants who has sufficiently recovered from surgery to tolerate an intensive exercise evaluation
- •Participants who have received a living-donor or cadaveric (from dead donor) renal transplant
- •Participants who has been initiated tacrolimus as first-line immunosuppressive agent
- •Participants who has given informed consent forms
排除标准
- •Participants with significant disease or disability that prevents taking part in a diet or exercise regime (e.g. cardiac instability, including unstable angina [chest pain due to decreased oxygen being supplied to the heart] and/or other unstable disease, severe cognitive [mental functioning] impairment)
- •Participants with significant post-surgical complications that prevent participation in the exercise component of the study (e.g. wound dehiscence [pathologic process consisting of a partial or complete disruption of the layers of a surgical wound] or infection)
- •Participants with contraindications to maximal exercise testing or high-intensity progressive resistance training (e.g. proliferative diabetic or hypertensive retinopathy, un-repaired aneurysm, critical aortic stenosis, recurrent symptomatic hernias, New York Heart Association (NYHA) class-IV congestive heart failure)
- •Participants with non-ambulatory (mobility) status
- •Participants who require ongoing systemic immunosuppressive therapy for an indication other than renal transplant and this therapy is higher than that required for their kidney disease
研究组 & 干预措施
Tacrolimus With Diet and Exercise Intervention
Participants on tacrolimus for immunosuppression (drug which suppresses the body's immune response, used in transplantation and diseases caused by disordered immunity) will be provided with intensive dietary advice and supervised progressive resistance training (PRT) for a period of 6 months. Dosage and administration of tacrolimus will be as per Investigator's discretion.
干预措施: Tacrolimus With Diet and Exercise Intervention (Drug)
结局指标
主要结局
Percentage of Participants With Insulin Resistance
时间窗: Week 24
Percentage of participants with insulin resistance as defined by a Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) greater than 1. HOMA uses fasting glucose and insulin (or C-peptide) to assess beta-cell function and IR. HOMA-IR is used to estimate insulin resistance. HOMA-IR is calculated by equation: HOMA-IR=fasting plasma insulin (milliunit \[mU\] per liter \[L\]) \* fasting plasma glucose (millimole per liter \[mmol per L\]) divided by 22.5.
次要结局
- Percentage of Participants With Impaired Fasting Glycaemia (IFG)(Week 24)
- Bone Mineral Density(Baseline and Week 24)
- Percentage of Participants With Impaired Glucose Tolerance (IGT)(Week 24)
- Beta Cell Function(Baseline, Week 4, Week 12, and Week 24)
- Body Composition: Percent Body Fat(Baseline and Week 24)
- Hemoglobin A, Glycosylated (HbA1c)(Baseline, Week 4, Week 12 and Week 24)
- Percentage of Participants Compliant With Both Dietary Advice and Exercise Program and Non-Compliant With Dietary Advice or Exercise Program(Week 4, Week 12 and Week 24)
- Percentage of Participants With Diabetes Mellitus (DM)(Week 24)
- Body Composition: Lean Mass, Bone Mass and Adjusted Weight(Baseline and Week 24)
- 36-Item Short-Form (SF-36) Score - Health Survey(Baseline, Week 12 and Week 24)
- Number of Participants With Acute Rejection, Graft Loss and Death(Week 24)
- Body Mass Index (BMI)(Baseline, Week 4, Week 12 and Week 24)
- Blood Pressure: Systolic and Diastolic Pressure(Baseline, Week 4, Week 12 and Week 24)
- Lipid Profile(Baseline, Week 4, Week 12, and Week 24)
- Body Composition: T Score (Full Body) and Z Score (Full Body)(Baseline and Week 24)
- Estimated Glomerular Filtration Rate (eGFR)(Baseline, Week 4, Week 12 and Week 24)
- Percentage of Participants who will be Sedentary, Insufficiently Active and Sufficiently Active According to Active Australia Survey (AAS)(Week 4, Week 12 and Week 24)
- Waist to Hip Ratio (WHR)(Baseline, Week 4, Week 12 and Week 24)