Personalized Dietary Management in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 294
- 试验地点
- 2
- 主要终点
- Mean Amplitude of Glycemic Excursion (MAGE)
研究概览
简要总结
In a randomized trial of 255 participants with early-stage T2D, participants will be randomized to 1 of 3 groups: Standardized, Personalized, or a Usual Care Control (UCC). In the first phase, participants will be randomized with equal allocation to these 3 groups. In the second phase (current phase), the remaining participants will be randomized with equal allocation to the Standardized and UCC groups.
详细描述
Type 2 diabetes (T2D) is an epidemic in the United States, affecting 30.2 million people. Vascular complications of T2D (heart and kidney disease, stroke, retinopathy, and amputation) are associated with poor glycemic control. However, the results of recent clinical trials (ACCORD, ADVANCE, VADT) to aggressively reduce HbA1c with medications have not resulted in cardiovascular benefits and may even be harmful due to risks of polypharmacy. Although HbA1c is directly associated with vascular complications, there is growing evidence that glycemic variability (or GV, defined by postprandial excursions and hypoglycemic nadirs) may be a better treatment target.
Postprandial glycemic excursions are primarily driven by diet. However, the results of dietary intervention studies intended to control postprandial excursions in T2D patients have been mixed and mostly negative. Importantly, these studies used one-size-fits-all dietary strategies that did not consider the fact that individuals vary greatly in their glycemic response to same foods. One-size-fits-all approaches are frustrating to T2D patients who have glycemic excursions despite their best efforts. And failure to adequately manage glycemia in the early stages of the disease has long-term vascular consequences that are not entirely remedied by subsequent, better glycemic control.
Personalized medicine is defined as "the right treatment for the right person at the right time" and has grown out of dramatic advances in genetic testing, molecular profiling, and mobile health (mHealth) technology. Personalizing dietary recommendations to the patient's unique glycemic response to food, using an algorithm derived from the gut microbiome to predict postprandial glycemic response (PPGR), is a proactive approach to early T2D dietary management that could increase mastery and self-management success beyond what can be achieved through a one-size-fits-all diet. The investigators also argue that such an approach could reduce glycemic exposure, preserve β-cell function, and reduce downstream metabolic consequences of T2D.
The purpose of this clinical trial is to determine the efficacy of a Personalized behavioral approach for dietary management of early-stage T2D, versus a Standardized behavioral intervention (which uses one-size-fits-all dietary recommendations), versus a UCC.
Primary aims. Compared to UCC, the study will determine the incremental benefits of Standardized and Personalized interventions on mean amplitude of glycemic excursion (or MAGE, the most frequently used measure of GV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Randomization is performed by the statistician blind to participant identity and baseline data. It is not possible to blind interventionists to randomization group. Outcome assessors will be blind to randomization assignment to the extent possible.
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must be an adult 21-80 years of age
- •must be diagnosed with early-stage T2D defined as HbA1c<8% and managed for the past 3 months on a diabetes regimen that included lifestyle plus metformin.
- •those who are willing and able to use a smart phone to self monitor their diet and to attend WebEx sessions
排除标准
- •those who have conditions or treatments likely to alter the underlying function of the microbiome, an insulin response that is driven by factors other than glycemic response to food, conditions/treatments that make it difficult to isolate the true nature of the relationship between randomization assignment and weight loss, characteristics or preferences that would preclude meaningful participation in the study
- •those who are unable or unwilling to adhere to an intervention that requires dietary self-monitoring
- •those who have been prescribed: (1) antibiotics or antifungals in the past 3 months, (2) diabetic medications other than metformin, (3) weight loss medications, (4) chronic use of steroids or immunosuppressants, (5) atypical antipsychotics, and (6) chemotherapy.
- •those who are pregnant, planning to become pregnant during the study period, or become pregnant during the study
- •those who have a chronic disease that affects energy/glucose metabolism (e.g., Cushing's syndrome, acromegaly, hyperthyroidism)
- •those who require special dietary management (end-stage kidney disease, cirrhosis, HIV)
- •those who are unable or unwilling to provide informed consent
- •those who are unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., uncorrected sight impairment, illiterate, non-English-speaking, dementia)
- •those who are unwilling to accept randomization assignment
- •those who have limited control over diet (e.g., are homeless or institutionalized, in a nursing home or personal care facility, or incarcerated)
- •those who have previously had bariatric surgery, or are unwilling to delay bariatric surgery for the next 7 months
- •those who are unable to walk without a walker or cane for 2 city blocks
- •those who have been diagnosed with a chronic active inflammatory or neoplastic disease in the past 3 years
- •those who have been diagnosed with a chronic gastrointestinal disorder (e.g., inflammatory bowel disease or celiac disease)
- •those who have an active substance use disorder
研究组 & 干预措施
Personalized
Dietary counseling to follow a Mediterranean-style diet personalized to reduce postprandial glycemic response
干预措施: Personalized Guidance to Minimize Postprandial Glycemic Response (PPGR) (Behavioral)
Usual Care Control (UCC)
Baseline advice about the Mediterranean-style diet and attention control.
干预措施: Usual Care Control (UCC) (Behavioral)
Standardized
One-size-fits-all dietary counseling to follow a Mediterranean-style diet
干预措施: Standardized (Behavioral)
Standardized
One-size-fits-all dietary counseling to follow a Mediterranean-style diet
干预措施: Usual Care Control (UCC) (Behavioral)
Personalized
Dietary counseling to follow a Mediterranean-style diet personalized to reduce postprandial glycemic response
干预措施: Standardized (Behavioral)
Personalized
Dietary counseling to follow a Mediterranean-style diet personalized to reduce postprandial glycemic response
干预措施: Usual Care Control (UCC) (Behavioral)
结局指标
主要结局
Mean Amplitude of Glycemic Excursion (MAGE)
时间窗: Month 6
MAGE will be evaluated via a continuous glucose monitor (CGM), which captures interstitial glucose readings every 15 minutes for up to 2 weeks from a sensor inserted into the participant's upper arm.
次要结局
- HbA1c Levels(Month 6)
- HbA1c Levels(Month 3)