The Effects of Dietary Supplements on Glycemic Control, Body Composition and Hepatic Fat Content in People With Prediabetes: a Randomized, Double-blind, Placebo-controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- changes in the time in range
研究概览
简要总结
This clinical study aims to explore the effects of 3 dietary supplements on metabolic parameters, liver fat content, and body composition in individuals with prediabetes. Prediabetes refers to a condition where blood sugar levels are higher than normal but not high enough for a diabetes diagnosis. The study will last for three months, during which participants will either take a dietary supplement or a placebo. Five groups will be studied, including placebo groups. Blood tests will assess glucose and lipid metabolism parameters, adipokines, and liver and kidney function. Liver stiffness and fat content will also be measured using elastography. Additionally, body composition will be assessed, and participants' psychological state, quality of life, eating habits and sports habits will be evaluated using questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •willingness and ability to provide written informed consent and comply with all study requirements,
- •age between 40 and 80 years
- •prediabetes with a HbA1c level between 5,7-6,4%
- •no antidiabetic treatment prior to the inclusion in the study
- •BMI between 25 and 35 kg/m2
- •fasting glucose of 100-125mg/dl
- •in the case of women of childbearing potential, providing a negative pregnancy test at inclusion and once a month until the end of the study
排除标准
- •failure to provide written informed consent and/or failure to comply with the study requirements
- •age <40 years
- •HbA1c outside of the set range
- •significant impairments of hepatic and/or renal function
- •clinically significant abnormalities in medical history, routine laboratory screening, or in physical examination
- •allergies against any of the components of the dietary supplements or the placebo
- •type 1 diabetes mellitus, latent autoimmune diabetes in adults, maturity-onset diabetes of the young, gestational diabetes
- •pregnancy, lactation
- •concurrent treatment with any antidiabetic drug
- •concurrent treatment with drugs/dietary supplements that have proven interactions with dietary supplements included in our study
结局指标
主要结局
changes in the time in range
时间窗: 2 weeks at baseline before start of the dietary supplement, 2 weeks during the last 2 weeks of the 3 month dietary supplement ingestion phase
time in range measured with continuous glucose monitoring system
次要结局
- changes in parameters of lipid metabolism(baseline, after 3 months)
- changes in fasting glucose concentration(baseline, after 3 months)
- changes in HbA1c values(baseline, after 3 months)
- changes in fasting insulin concentration(baseline, after 3 months)
- changes in fasting c-peptide concentration(baseline, after 3 months)
- changes in HOMA-IR(baseline, after 3 months)
- changes in adipokine levels(baseline, after 3 months)
- changes in the hepatic fat content(baseline, after 3 months)
- changes in the hepatic fibrosis amount(baseline, after 3 months)
- changes in parameters of hepatic function(baseline, after 3 months)
- changes in bilirubin concentrations(baseline, after 3 months)
- changes in the weight(baseline, after 3 months)
- changes in the BMI(baseline, after 3 months)
- changes in the anthropometric parameters(baseline, after 3 months)
- changes in depressive, anxiety and stress-related symptoms(baseline, after 3 months)
- changes in quality of life(baseline, after 3 months)
研究者
Michael Leutner
Priv.Doz. Dr.med.univ.
Medical University of Vienna