Effect of Whole Fruit on Glycemic Control in Adults With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Diabetes Remission Rate
研究概览
简要总结
Diabetes costs the U.S. healthcare system more than any other disease, and nearly half of Americans will develop either diabetes or prediabetes in their lifetime. It is therefore critical to find new strategies to treat or reverse diabetes.
One such approach is adopting a healthy diet, which can dramatically improve blood sugar levels in adults with type 2 diabetes and even induce diabetes remission. Despite this, not much is known about which food groups are most effective at improving blood sugar levels in patients with diabetes.
Interestingly, of the various food groups, epidemiologic data suggests that whole fruit may be one of the most efficacious at both preventing type 2 diabetes and improving blood sugar in patients with type 2 diabetes. However, few clinical trials have investigated the effects of whole fruit on blood sugar control. This study will therefore be the first to determine the effects of increasing whole fruit as a food group in type 2 diabetes patients. This supervised controlled feeding trial will test whether consuming a diet rich in whole fruit for 12 weeks can improve glycemic control and cardiometabolic health in weight-stable adults with type 2 diabetes. The primary endpoint is glycemic control. Since changes in medication doses can skew the interpretation of glycemic outcomes, glycemic control will be assessed hierarchically (in descending order of importance) using (a) attainment of nondiabetic glycemia without medications (as a proxy for diabetes remission), (b) medication effect scores, (c) mean glucose during an oral glucose tolerance test, and (d) 24-hour mean glucose from continuous glucose monitoring. As secondary aims, this study will also test whether consuming a large amount of fructose in whole food form affects liver fat, pancreatic fat, and cardiovascular disease risk factors.
详细描述
Pre-registration notes: The primary endpoint is glycemic control, which will be analyzed hierarchically in descending order of importance as:
- Diabetes remission rate (endpoint #1)
- Medication effect score (endpoint #2)
- Fasting glucose and HbA1c (endpoints #3-4)
- Oral glucose tolerance test and continuous glucose monitoring measures (endpoints #5-14)
while the secondary endpoints (endpoints #15-20) will all be evaluated with equal importance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Lab values and week 0, 4, and 12 endpoints are assessed blinded by individuals not affiliated with the protocol. Also, data cleaning will be performed while being blinded to the timepoint.
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-70 years old
- •BMI ≤45.0 kg/m^2
- •First diagnosed with type 2 diabetes within the past 6 years
- •HbA1c between 6.0-9.5%%
排除标准
- •On insulin
- •Diagnosis of diabetes before age 18
- •Estimated glomerular filtration rate < 45 ml/min per 1.732 m^2
- •Heart attack in the past 6 months or severe or unstable heart failure
- •On weight loss medication
- •Change in the dosage of a chronic medication that may affect study endpoints within the past 3 months
- •Clinically significant laboratory abnormality (e.g. abnormal hemoglobin levels)
- •Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones
- •Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise safety or data validity
- •Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years
- •Lost or gained more than 5 kg of weight in the past 6 months
- •Pregnant, planning to become pregnant in the next 12 months, or breastfeeding
- •Major psychiatric condition that would affect the ability to participate in the study
- •Not able to eat the provided study meals
- •Behavioral factors or circumstances that may impede adhering to the dietary intervention
- •Not able to do the MRI/MRS abdominal scan, such as due to claustrophobia, implanted metal objects, or a body girth of 60 cm or greater
研究组 & 干预措施
High-Fruit Diet
Whole fruit-rich diet (~50% of calories from whole fruit)
干预措施: High-Fruit Diet (Behavioral)
结局指标
主要结局
Diabetes Remission Rate
时间窗: Change from baseline to week 12
Percentage of patients who can maintain non-diabetic levels 24-hour mean glucose without the aid of pharmacotherapy at week 12
Mean 24-hour Glucose Levels as Measured by Continuous Glucose Monitoring (CGM), Adjusted for Any Changes in Medication Doses Via the MES
时间窗: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported.
mg/dl
Medication Effect Score (MES)
时间窗: Change from baseline to Week 12
% (or percentage). This quantity estimates the percentage by which all anithyperglycemic medications taken by a patient would lower HbA1c levels (i.e., percent of glycated hemoglobin molecules). Higher values indicate a higher dose and/or potency of medications.
Mean Glucose During a 3-hour Oral Glucose Tolerance Test (OGTT)
时间窗: Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported.
mg/dl
次要结局
- Insulin Sensitivity(Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported.)
- Mean Insulin During a 3-hour OGTT(Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported.)
- Mean C-peptide During a 3-hour OGTT(Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported.)
- Mean Amplitude of Glycemic Excursions From CGM(Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints)")
- Fasting Glucose(Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints))
- HbA1c(Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints))
- Liver Fat (Intrahepatic Lipid)(Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints))
- Pancreatic Fat(Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints))
- Systolic and Diastolic Blood Pressure(Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints))
- Heart Rate(Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints))
- Time-in-range Metrics From CGM(Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints))
- Lipids(Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints))
- Dynamic Beta-Cell Responsivity(Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported.)
- Static Beta-Cell Responsivity(Changes from weeks 0 to 12 (primary timepoint) and weeks 0 to 4 and 4 to 12 (secondary timepoints). Change from week 0 to 12 reported.)
研究者
Courtney M Peterson
Associate Professor
University of Alabama at Birmingham