Effect of Apple Cider Vinegar in Type 2 Diabetics
1 other identifier
interventional
126
1 country
1
Brief Summary
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. .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2017
CompletedFirst Submitted
Initial submission to the registry
June 24, 2018
CompletedFirst Posted
Study publicly available on registry
July 19, 2018
CompletedJuly 19, 2018
July 1, 2018
4 months
June 24, 2018
July 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c (Glycosylated Hemoglobin)
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.
3 months
Secondary Outcomes (2)
blood sugar fasting
3 months
fasting lipid profile
3 months
Study Arms (2)
Intervention group
EXPERIMENTALIntervention 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.
Comparison group
PLACEBO COMPARATORControl 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.
Interventions
15ml apple cider vinegar (American garden organic vinegar) (containing 5% acetic acid) mixed in 200ml water during meal at night time, for 3 months and tablet Tagipmet 50mg/1000mg (Metformin + Sitagliptin group) twice a day. NOTE medical treatment is our inclusion criteria.
Flavor of apple cider vinegar in 200 ml water is added and given to have a placebo effect and tablet Tagipmet 50mg/1000mg (Metformin + Sitagliptin group) twice a day. NOTE medical treatment is our inclusion criteria.
Eligibility Criteria
You may qualify if:
- 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 20-30.
- Non alcoholics.
- Non smoker.
- All were on standard medical therapy for diabetes (including Metformin + Sitagliptin group).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shaikh Zayed Medical Complex
Lahore, Punjab Province, 54000, Pakistan
Related Publications (1)
Clarke P. Seat belts. Lancet. 1977 May 28;1(8022):1155. doi: 10.1016/s0140-6736(77)92414-x. No abstract available.
PMID: 68254BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Single-blinded trial, Intervention and placebo given
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Nutritionist
Study Record Dates
First Submitted
June 24, 2018
First Posted
July 19, 2018
Study Start
July 15, 2017
Primary Completion
November 14, 2017
Study Completion
November 14, 2017
Last Updated
July 19, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share