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临床试验/NCT02834715
NCT02834715已完成不适用

Effects of Stevia on Glycaemic Profile and Insulin Secretion of Type 2 Diabetic Patients

Yaounde Central Hospital1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2016年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Glycaemic profile in response to mixed meal test

研究概览

简要总结

The main aim of the study is to assess the short term and 1-month metabolic effects of Stevia rebaudiana bertoni in patients with type 2 diabetes.

详细描述

This is a non-randomized clinical trial in a type 2 diabetic population aiming to investigate the effect of Stevia rebaudiana bertoni on the glycaemic and insulin secretory response to a mixed meal tolerance test, insulin sensitivity and lipid profile. The study has two arms including an intervention arm (test group) and a non-intervention arm (controls) matched for age, sex and body mass index in 2:1 ratio.

The intervention is made of two phases including

  1. A mixed meal tolerance test with and without 240 mg of Stevia in a randomized order to evaluate the acute effects;
  2. An oral intake of 240 mg of Stevia within 30 days as food supplement in order to assess medium-term effects

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Known type 2 diabetes
  • Unchanged hypoglycaemic treatment for at least 3 months prior to inclusion
  • No acute complication of diabetes
  • HbA1C≤ 8%

排除标准

  • Infection up to 10 days prior to inclusion
  • Serum ALAT >3N,
  • MDRD estimated creatinine clearance <60ml/min
  • Tobacco smoking

结局指标

主要结局

Glycaemic profile in response to mixed meal test

时间窗: 1 month

Change in blood glucose profile during a mixed meal test at baseline and after one month intervention

次要结局

  • insulin secretion in response to mixed meal test(1 month)
  • Serum lipids(1 month)
  • Insulin sensitivity(1 month)
  • Liver enzymes(1 month)

研究者

发起方
Yaounde Central Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sobngwi Eugene

Professor

Yaounde Central Hospital

研究点 (1)

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