Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in Hemoglobin A1c
研究概览
简要总结
The proposed randomized controlled trial will test the effect of a low-carbohydrate diet on hemoglobin A1c among individuals with elevated hemoglobin A1c that are within the range of prediabetes or diabetes. Results may provide evidence about the role of carbohydrate restriction in individuals with or at high risk of type 2 diabetes.
详细描述
In the short-term, among patients with type 2 diabetes, low-to-moderate carbohydrate diets have a greater glucose-lowering effect than do high-carbohydrate diets. However, compared with usual diet, the effect of a behavioral intervention promoting a low-carbohydrate/high-unsaturated fat and high-protein dietary pattern among individuals with prediabetes or untreated type 2 diabetes is not well understood.
The overall goal of this randomized controlled trial is to study the effect of a behavioral intervention promoting a low-carbohydrate/high-unsaturated fat and high-protein dietary pattern compared with usual diet on hemoglobin A1c (HbA1c) and other metabolic risk factors among individuals with or at high risk of diabetes (HbA1c 6.0-6.9%).
A total of 150 participants with HbA1c 6.0-6.9% will be recruited and randomly assigned to either a 6-month behavioral modification program designed to reduce carbohydrate intake (initial target <40 g digestible carbohydrates, final target <60 g digestible carbohydrates) or to usual diet in a 1:1 randomization ratio.
The primary outcome will be the difference between the active intervention and control groups for change in HbA1c from baseline to 6 months. Secondary outcomes will be fasting glucose, systolic blood pressure, total-to-high-density lipoprotein-cholesterol ratio, and body weight.
Findings from this study may provide evidence about the role of carbohydrate restriction in individuals with or at high risk of type 2 diabetes.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women ages 40 to 70 years
- •HbA1c 6.0-6.9%
- •Willing and able to provide informed consent
排除标准
- •Diagnosed type 1 diabetes mellitus
- •Use of agents affecting glycemic control (medications for diabetes, oral glucocorticoids) within the past three months prior to enrollment
- •Medical condition in which low-carbohydrate diet may not be advised: estimated glomerular filtration rate (eGFR) ≤45 mL/min/1.73 m²; self-report of liver disease due to hepatitis or alcohol; osteoporosis; untreated thyroid disease; gout; cancer (other than non-melanoma skin cancer) requiring treatment in the past year, unless prognosis is excellent
- •Factors that may affect HbA1c: hemoglobin <11 mg/dL (cutpoint for moderate-to-severe anemia, which could lead to falsely elevated or lowered HbA1c); recent blood donation or blood transfusion (self-report, past 4 months); human immunodeficiency virus (self-report)
- •Self-reported history of intensive care unit stay due to Coronavirus Disease 2019 (COVID-19) in the past three months, as severe COVID-19 may affect blood glucose levels
- •Allergies to nuts
- •For women, current pregnancy, breastfeeding, or plans to become pregnant during the study
- •Consumption of ≥21 alcoholic drinks per week or consumption of ≥6 drinks per occasion
- •Current or planned residence making it difficult to meet trial requirements (due to distance from study site and/or challenges regularly traveling to site)
- •Current participation in another lifestyle intervention trial or a pharmaceutical trial
- •Participation of another household member in the study; employees or persons living with employees of the study
- •Other concerns regarding ability to meet trial requirements, at the discretion of the principal investigator or study coordinator
结局指标
主要结局
Change in Hemoglobin A1c
时间窗: Baseline and six months
6-month change in Hemoglobin A1c comparing low-carbohydrate arm with usual diet arm
次要结局
- Change in Fasting Plasma Glucose(Baseline and six months)
- Change in Systolic Blood Pressure(Baseline and six months)
- Change in Body Weight(Baseline and six months)
- Change in Total-to-HDL-cholesterol Ratio(Baseline and six months)
研究者
Kirsten Dorans
Assistant Professor
Tulane University School of Public Health and Tropical Medicine