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Effect of Apple Cider Vinegar in Type 2 Diabetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03593135
Recruitment Status : Completed
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Sofia Kausar, Sheikh Zayed Federal Postgraduate Medical Institute

Study Description
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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.

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Condition or disease Intervention/treatment Phase
Randomized Controlled Trial Diabetes Mellitus Dietary Supplement: Apple Cider Vinegar and tablet Tagipmet (Metformin + Sitagliptin group) Other: Water with Apple Cider vinegar flavor and tablet Tagipmet (Metformin + Sitagliptin group) Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Single (Participant)
Masking Description: Single-blinded trial, Intervention and placebo given
Primary Purpose: Treatment
Official Title: Effect of Apple Cider Vinegar in Type 2 Diabetic Patients With Poor Glycemic Control: a Randomized Controlled Design
Actual Study Start Date : July 15, 2017
Actual Primary Completion Date : November 14, 2017
Actual Study Completion Date : November 14, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Dietary Supplement: Apple Cider Vinegar and tablet Tagipmet (Metformin + Sitagliptin group)
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.
Other Name: intervention
Placebo Comparator: 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.
 Other: Water with Apple Cider vinegar flavor and tablet Tagipmet (Metformin + Sitagliptin group)
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.
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. HbA1c (Glycosylated Hemoglobin) [ Time Frame: 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.


Secondary Outcome Measures :
  1. blood sugar fasting [ Time Frame: 3 months ]
    Before start of intervention and after intervention 5ml venous blood sample was taken with 12 hours fasting for biochemical analysis of blood sugar fasting in sterilized dray tubes,commercial kits of Siemens for Dimmension XL and photometric methods for analysis was used.

  2. fasting lipid profile [ Time Frame: 3 months ]
    Before start of intervention and after intervention 5ml venous blood sample was taken with 12 hours fasting for biochemical analysis of fasting lipid profile commercial kits of Rodex for Dimmension Rxl and photometric methods for analysis were used.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593135


Locations
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Pakistan
Shaikh Zayed Medical Complex
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
Sheikh Zayed Federal Postgraduate Medical Institute
More Information
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Publications:

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Responsible Party: Sofia Kausar, Clinical Nutritionist, Sheikh Zayed Federal Postgraduate Medical Institute
ClinicalTrials.gov Identifier: NCT03593135    
Other Study ID Numbers: 1481
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sofia Kausar, Sheikh Zayed Federal Postgraduate Medical Institute:
vinegar
diabetes
hyperglycemia
hypercholesterolemia
nutraceutical
Additional relevant MeSH terms:
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Metformin
Sitagliptin Phosphate
Acetic Acid
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents