Effect of Dietary Energy Restriction on Reversing Isolated Impaired Fasting Glucose: A Proof of Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
This study aims to evaluate the preliminary efficacy of a low-calorie diet (LCD) intervention in addressing the underlying pathophysiological abnormalities and improving fasting hyperglycemia among individuals with isolated impaired fasting glucose (i-IFG). Additionally, it seeks to assess the feasibility and acceptability of the LCD intervention.
详细描述
This proof-of-concept randomized controlled trial (RCT) will enroll 34 individuals aged 35-65 years with overweight or obesity and isolated impaired fasting glucose. Intervention participants will adhere to an 8-week low-calorie dietary (LCD) regimen (~1,320 kcal/day) comprising specific macronutrient proportions (55% carbohydrate, 13% fat, 25% protein, and 2% fiber). Control participants will maintain their habitual dietary habits and physical activity levels. Primary outcomes at 8 weeks include between-group changes in weight, fasting plasma glucose, indices of ß-cell function and hepatic insulin resistance, and alanine aminotransferase levels. Secondary outcomes are feasibility metrics (response rate, screening yield, enrollment rate, intervention compliance, cost, staff time, and retention rate) and intervention acceptability. Qualitative research will explore facilitators, barriers, acceptability, satisfaction, and participant experiences with the LCD intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Nursing staff conducting outcome assessments and laboratory personnel will be blinded to participants' treatment status.
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 35 to 65 years
- •Overweight (body mass index (BMI) ≥25 to <29 kg/m² or ≥23 to <29 kg/m² if Asian descent) or Obese (BMI ≥30 kg/m²)
- •Physically inactive (<150 minutes per week of moderate-intensity physical activity or <75 minutes per week of vigorous-intensity physical activity)
- •Prediabetes diagnosis or score ≥5 on the American Diabetes Association (ADA) risk tool
排除标准
- •Diagnosed with type 1 or type 2 diabetes
- •Cardiovascular disease (myocardial infarction, stroke, angina, heart failure, or other cardiac conditions)
- •Chronic kidney disease
- •Chronic liver disease (e.g., cirrhosis)
- •Acute inflammatory bowel disease, irritable bowel syndrome, celiac disease, chronic pancreatitis, or other disorders potentially causing malabsorption
- •Food allergies
- •Participation in weight loss programs in the past six months
- •Currently following a specific diet (e.g., ketogenic diet, Mediterranean diet)
- •Participation in any exercise programs in the past six months
- •Currently taking weight-loss medications or drugs known to affect glycemia (steroids and antipsychotics)
- •Previous bariatric surgery or plan to have bariatric surgery during the study period
- •Planning to relocate during the study period
- •Intending to fast during the study period for religious or other reasons
- •Pregnancy or planning to become pregnant during the study period
- •Breastfeeding
- •Non-English speaker
研究组 & 干预措施
Low-calorie diet
Participants following a low-calorie diet (LCD) consisting of approximately 1,300 kcal/day (37% carbohydrates, 25% protein, 39% fat, and 7 g of fiber per meal) over an eight-week period.
干预措施: Low-calorie diet (Behavioral)
Routine dietary and physical activity habits
Control participants are asked to maintain their routine dietary and physical activity habits.
干预措施: Routine dietary and physical activity habits (Behavioral)
结局指标
主要结局
Response rate
时间窗: Baseline
Response rate is defined as the proportion of individuals responding to the invitation sent via the Epic database.
Screening yield
时间窗: Baseline
Screening yield: Proportion of screened individuals meeting eligibility criteria.
Enrollment rate
时间窗: Baseline
Enrollment rate: Proportion of eligible individuals who enroll in the study.
Resource utilization
时间窗: Throughout the study period, an average of 10 weeks
Resource utilization: Assessment of expenditures and staff time.
Retention rate
时间窗: 4 and 8 weeks
Retention rate: Proportion of enrolled participants who complete the study.
Intervention acceptability
时间窗: 4 and 8 weeks
Intervention acceptability will be assessed using the Theoretical Framework of Acceptability questionnaire. Scores range from 7 to 35. Higher scores indicate better acceptability among participants.
Feasibility of intervention
时间窗: 4 and 8 weeks
Will be assessed using the Feasibility of Intervention Measure questionnaire. Scores range from 4 to 20. Higher scores indicate better feasibility among participants.
Intervention appropriateness
时间窗: 4 and 8 weeks
Will be assessed with the Intervention Appropriateness Measure questionnaire. Scores range from 4 to 20. Higher scores indicate better appropriateness among participants.
Facilitators, barriers, acceptability, satisfaction, and participant experiences with the the intervention
时间窗: 4 and 8 weeks
Qualitative in-depth interviews
次要结局
- Weight in kg(4 and 8 weeks)
- Fasting plasma glucose in mg/dl(4 and 8 weeks)
- Indices of ß-cell function(4 and 8 weeks)
- ß-cell function assessed by Oral Disposition Index (DI(O))(4 and 8 weeks)
- ß-cell function assessed by Homeostatic Model Assessment of ß-cell Function (HOMA-B)(4 and 8 weeks)
- Indices of hepatic insulin resistance(4 and 8 weeks)
- Alanine aminotransferase (liver enzyme) in U/L(4 and 8 weeks)
研究者
Mary Beth Weber
Associate Professor
Emory University