Effect of Artificially Sweetened Beverages on Diabetes 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
- 181
- 试验地点
- 4
- 主要终点
- HbA1c
研究概览
简要总结
Diet beverages sweetened with artificial sweeteners occupy a unique category in the food environment as they are a source of intensely sweet taste with no calories. Diet beverages are the single largest contributor to artificial sweetener intake in the U.S. diet, and people with diabetes are the highest consumers of diet beverages, tending to consume them as a replacement for dietary sources of sugar, especially in place of sugar-sweetened beverages. This behavior has been endorsed by dietetic and scientific organizations, and diet beverages are marketed as being synonymous with better health, suitable for weight loss, and thus advantageous for diabetes control. The underlying public health concern is that there are few data to support or refute the benefit or harm of habitual diet beverage consumption by people with diabetes; therefore randomized trials with relevant outcomes must be conducted because they would address many limitations of previous research and have major implications for dietary recommendations on diet beverage intake and primary and secondary prevention of chronic disease. To begin addressing this important scientific gap the investigators are testing the effect of diet beverage intake on diabetes control parameters in free-living adults with type 2 diabetes in a randomized, two arm parallel trial with a run-in period of 2-weeks and an active intervention period of 24-weeks. This study will recruit 200 patients with type 2 diabetes who are usual consumers of commercial diet beverages and randomize them to receive and consume either: 1) A commercial diet beverage of choice (3 servings or 24 oz. daily); or 2) Unflavored bottled water of choice (sparkling or plain) (3 servings or 24 oz. daily). The primary outcome will be a central measure of clinical diabetes control in glycated hemoglobin (HbA1c). The study will also measure the nature and magnitude of glycemic excursions via continuous glucose monitors, as well as clinical markers of cardiometabolic risk and kidney function. Lastly, investigators will measure plausible mechanisms whereby diet beverage intake may alter risk by assessing the effect of diet beverage intake on the functional composition of the gut microbiome via stool samples and comprehensive metabolomics, satiety hormones, as well as usual dietary intake, and upstream behavioral pathways which may inform dietary intake patterns.
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
All nursing staff/phlebotomist collecting physical samples, and the lab analyzing the samples will be masked to the trial arm the participant is in. The biostatistician performing the final analyses will also be masked.
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Type 1 diabetes or suspected type 1 diabetes (lean with polyuria, polydipsia, and weight loss with little response to metformin)
- •"Secondary" diabetes due to specific causes (e.g. monogenic syndromes, pancreatic surgery, and pancreatitis)
- •Diabetic Ketoacidosis hospitalization within last 6 months
- •Severe/major hypoglycemia in the last 3 months-severe/major hypoglycemia is defined as a hypoglycemic event in which patient requires assistance of another person to manage the episode
- •Glucocorticoid use (prednisone 2.5 mg/d or more or its equivalent)
- •History of intolerance or allergy to diet beverages or AS or phenylketonuria
- •Any condition that is known to affect the validity of the glycemic measures (Hba1c)
- •Major cardiovascular disease event or surgery within past 6 months
- •Gastrointestinal disease
- •Renal or liver disease
- •Current treatment for cancer
- •Those with major surgery planned or history of bariatric surgery
- •Antibiotic treatment (> 6 days) within past 6 months
- •Currently pregnant (via self-report) or planning to become pregnant during study period; <1 year postpartum and breast feeding
- •Current participation in another interventional clinical trial
- •Previous randomization in this study,
- •Heavy alcohol consumption (on average >2 drinks/day for women and >3 drinks/day for men)
- •Habitual consumer of SSB ≥ 1 serving / day (8 oz.)
- •Does not drink diet beverages
- •BMI < 20.0 kg/m2
结局指标
主要结局
HbA1c
时间窗: Time 0 (directly after 2-week run-in), 12, 24 weeks
Glycated hemoglobin
次要结局
- Time In Range(All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days))
- Glycemic Variability(All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days))
- Time In Range(All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days))
- Glycemic Variability(All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days))
- Mean Glucose (mg/dl)(All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days))
- Fasting Glucose(Time 0 (directly after 2-week run-in), 12, 24 weeks)
- Fasting Insulin (Pmol/L)(Time 0 (directly after 2-week run-in), week 12, week 24)
- Fructosamine(Time 0 (directly after 2-week run-in),12, 24 weeks)
- Weight (kg)(Time 0 (directly after 2-week run-in), 12, 24 weeks)
- Total Cholesterol (mg/dL)(Time 0 (directly after 2-week run-in), 12, 24 weeks)
- Kidney Function(Time 0 (directly after 2-week run-in),12, 24 weeks)
- Systolic Blood Pressure(Time 0 (directly after 2-week run-in),12, 24 weeks)
- Diastolic Blood Pressure(Time 0 (directly after 2-week run-in), 12, 24 weeks)
- Apolipoprotein-AI(Time 0 (directly after 2-week run-in), 12, 24 weeks)
- Apolipoprotein B(Time 0 (directly after 2-week run-in), 12, 24 weeks)
- Fibrinogen (mg/dL)(Time 0 (directly after 2-week run-in), 12, 24 weeks)
- C-reactive Protein(Time 0 (directly after 2-week run-in), 12, 24 weeks)
- Aspartate Aminotransferase (AST) (U/L)(Time 0 (directly after 2-week run-in), 12, 24 weeks)
- Aminotransferase (ALT) (U/L)(Time 0 (directly after 2-week run-in), 12, 24 weeks)
- Alkaline Phosphatase (ALKPhos ) (U/L)(Time 0 (directly after 2-week run-in), 12, 24 weeks)
- Thyroid Stimulating Hormone (TSH)(Time 0 (directly after 2-week run-in), 12, 24 weeks)
- The Pittsburgh Sleep Quality Index (PSQI)(Time 0 (directly after 2-week run-in), 12, 24 weeks)
- Dietary Quality (Healthy Eating Index -HEI)(Run-in period (2 weeks) - baseline, Week 1-12 (period 1), Week 13-24 (period 2).)
- The Diabetes Health Profile (DHP-18)(Time 0 (directly after 2-week run-in), 12, 24 weeks)
- Food Craving Inventory (FCI)(Time 0 (directly after 2-week run-in), 12, 24 weeks)
- Medication Effect Score (MES)(Time 0 (directly after 2-week run-in), 6, 12, 18, 24 weeks)
- Therapeutic Intensity Score (TIS)(Time 0 (directly after 2-week run-in), 6, 12, 18, 24 weeks)
研究者
Andrew Odegaard
Associate Professor
University of California, Irvine