Effect of Apple Cider Vinegar in Type 2 Diabetic Patients With Poor Glycemic Control: a Randomized Controlled Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- HbA1c (Glycosylated Hemoglobin)
研究概览
简要总结
Background: apple cider vinegar is natural traditional health beneficial nutraceutical used for many aliments. Diabetes mellitus (DM) has been considered a globally major health problem and posing health burden on families and health system. Diabetes is associated with life style that leading to reduce physical activities and increased in obesity. For development of diabetes the known mechanism are endocrine disorders which cause impaired insulin secretion, hepatic glucose over production and insulin resistance.
Objective: The aim of current randomized controlled trial was to investigate the effect of apple cider vinegar on glycemic control and biochemical parameters in type 2 diabetic patients with poor glycaemic control.
Material & Methods: 110 type 2 diabetic patients according to inclusion criteria were selected and divided into two groups. Interventional group was given 15 ml apple cider vinegar in 200ml water during meal at night time for 3 months. Before and after HbA1C, fasting lipid profile, fasting blood sugar, anthropometrics and dietary changes were assessed and analyzed using IBM SPSS version 20 through paired sample T-test where needed.
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详细描述
A study conducted in pre-diabetic healthy individuals showed significant (p=0.05) reduction in HbA1C, in apple cider vinegar group . Many RCTs of human and animals showed hypolipidemic effects of ACV. Anti obesity effect of apple cider vinegar also found in many studies. There is still lot of work going on and this present study is conducted with an objective to measure the effect of apple cider vinegar on HbA1c, fasting blood glucose, fasting lipid profile and body weight.
METHOD:
STUDY DESIGN AND SETTING
This study was a single-blind, randomized-controlled placebo trial. Trial period was three months from August 15, to November 15, 2017. This study was conducted at a 1050 beded tertiary care, teaching hospital of Lahore, Pakistan. This hospital has high diabetics out-patient turnover as being a reputable center in management of diabetes.
PARTICIPANTS:
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 (Participant)
盲法说明
Single-blinded trial, Intervention and placebo given
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients having uncontrolled type 2 diabetes with raised HbA1c levels.
- •Both gender.
- •Age ranging from 30-60 years.
- •All having body mass index between 20-
- •Non alcoholics.
- •Non smoker.
- •All were on standard medical therapy for diabetes (including Metformin + Sitagliptin group).
排除标准
- •Patients suffering from known chronic renal disease.
- •History of cardiovascular diseases like stroke, ischemic heart disease.
- •Known allergy to vinegar.
- •intolerance to vinegar, reported by the patient or relative.
- •Any kind of acute infection were excluded from study.
研究组 & 干预措施
Intervention group
Intervention group taking their diet according to their original meal pattern only dietary guideline were given regarding high glycaemic and low glycaemic diet. Medical treatments continued (including tablet Tagipment 50mg/1000mg twice a day)(Metformin + Sitagliptin group). 15ml apple cider vinegar (American garden organic vinegar) (containing 5% acetic acid) mixed in 200ml water during meal at night time was prescribed.
干预措施: Apple Cider Vinegar and tablet Tagipmet (Metformin + Sitagliptin group) (Dietary Supplement)
Comparison group
Control group also taking their diet according to their original meal pattern only dietary guideline were given regarding high glycaemic and low glycaemic diet. Medical treatment continued (including tablet Tagipmet 50mg/1000mg twice a day)( Metformin + Sitagliptin group). Flavor of apple cider vinegar used as placebo, mixed in 200ml plain water during meal at night time.
干预措施: Water with Apple Cider vinegar flavor and tablet Tagipmet (Metformin + Sitagliptin group) (Other)
结局指标
主要结局
HbA1c (Glycosylated Hemoglobin)
时间窗: 3 months
Before start of intervention and after intervention 5ml venous blood sample was taken for biochemical analysis of HbA1C (glycosylated hemoglobin) in sterilized tubes,commercial kits of Siemens for Dimmension RxL used and the HbA1C measuement is based on a turbidimetric inhibition immunoassay (TINIA) priniciple.
次要结局
- blood sugar fasting(3 months)
- fasting lipid profile(3 months)
研究者
Sofia Kausar
Clinical Nutritionist
Sheikh Zayed Federal Postgraduate Medical Institute