Comparison of Laboratory Changes, Food Intake and Metabolic Profile in Patients With Obesity and Type2 Diabetes Mellitus: Before, During and After Taking AphoelineBrake
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Reduction in Insulin Resistance measured by HOMA-IR
研究概览
简要总结
The primary objective is to determine if subjects taking the natural product AphoelineBrake™ in addition to their standard treatment experience differences in metabolic disease control, gastrointestinal hormones and inflammatory markers diet, hunger, satiety, weight, compared to patients taking a placebo in addition to their standard treatment. The secondary objective is to study the effect of Aphoeline Brake on oxidative and inflammatory stress markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥21 years
- •Diagnosis of T2DM
- •Metformin as first line treatment
- •Calculated HOMA-IR ≥3.0,
- •BMI 25-45
- •Triglyceride level ≥ 2.26 mmol/L
排除标准
- •Age <21 years of age
- •Subjects on chronic nonsteroidal anti-inflammatory drugs or systemic corticosteroids.
- •Subjects treated with Liraglutide (Victoza®).
- •Renal, hepatic or cardiac failure.
- •Subjects with a significant clinical illness within a month before the first administration of Aphoeline Brake™
- •Subjects diagnosed with Irritable Bowel Syndrome.
- •Subjects diagnosed with Ulcerative Colitis or Crohn's disease.
- •History of significant gastrointestinal disease.
- •Poor venous access.
- •Poor likelihood to adhere with study procedures, as documented during the MyFitnessPal procedures prior to use of Aphoeline Brake™
研究组 & 干预措施
Active
AphoelineBrake administration
干预措施: AphoelineBrake (Drug)
Placebo
Placebo Administration
干预措施: AphoelineBrake (Drug)
结局指标
主要结局
Reduction in Insulin Resistance measured by HOMA-IR
时间窗: 12 months from intervention
Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin levels.
Reduction in glycated Haemoglobin measured: HBA1c
时间窗: 12 months from intervention
HbA1c refers to glycated haemoglobin. It develops when haemoglobin, joins with glucose in the blood.
次要结局
- Reduction in serum triglyceride level (mmol/l)(12 months from intervention)