Effect of Apple Cider Vinegar and Metformin Combination vs Metformin Alone in Type 2 Diabetics

October 17, 2019 updated by: Dr Momina Abid, Ziauddin University

Effect of Apple Cider Vinegar and Metformin Combination vs Metformin Alone in Type 2 Diabetics:A Randomized Controlled Trial

'This study aims to compare the effect of Metformin alone vs Metformin plus Apple Cider Vinegar in newly diagnosed Type 2 Diabetic Patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetes Mellitus is one of the oldest diseases known to men and has been treated with multiple agents,organic and with the current pharmacological advancement,with multiple synthetic drugs as well.

Metformin has been considered first line for the treatment of Type 2 Diabetes, however presents itself with a side effect profile of GI distress, Vitamin B12 deficiency,to name a few.

Vinegar has been used as therapeutic agent for centuries for multiple ailments including diabetes. This study aims to evaluate the combined effects of drug and natural therapy and compare it with conventional therapy.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 7500
        • Ziauddin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recently diagnosed Type 2 diabetic patients taking metformin 750 mg daily as the oral antidiabetic agent
  • Patients with Hemoglobin A1c in the range of 6.5 to 7.5%

Exclusion Criteria:

  • All newly diagnosed Diabetic Patients requiring a dosage other than 750 mg per day
  • Patients on Insulin Therapy or any drugs for diabetes other than Metformin
  • Pregnant and Lactating women
  • Patients with food allergies to either apple or any source of vinegar
  • Patients unable to communicate efficiently\mentally challenged
  • Type 2 Diabetic patients with any of the complications of long standing uncontrolled diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Intervention: Metformin Tablet oral 750 mg OD
Drug: Metformin Oral Tablet
A biguanide drug used as a first line therapy for Diabetes MellitusType 2
Experimental: Group 2
Intervention: Metformin 750 mg oral plus 2 tablespoons of apple cider vinegar OD
Drug: Metformin Oral Tablet
A biguanide drug used as a first line therapy for Diabetes MellitusType 2
Dietary supplement: Vinegar
A common herbal/dietary supplement used for centuries as an anti bacterial, cleaning,cooking, anti diabetic agent, to name a few uses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI (Anthropometric Measurement)
Time Frame: 12 weeks
Body Mass Index: A measure of obesity calculated as weight in kilograms divided by height in meters square
12 weeks
Measurement of Hemoglobin A1c
Time Frame: 12 weeks
A blood test for Glycated Hemoglobin that represents a 2-3 month glycemic control
12 weeks
Measurement of Fasting Blood Sugar
Time Frame: 12 weeks
A blood test that involves the measurement of plasma glucose after 8 to 12 hours of fasting
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziauddin University

Investigators

  • Principal Investigator: Dr Momina Abid, MBBS,M Phil (ongoing), Ziauddin University
  • Principal Investigator: Dr Zahida Memon, MBBS,M Phil,PhD, Ziauddin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2019

Primary Completion (Actual)

August 26, 2019

Study Completion (Actual)

August 26, 2019

Study Registration Dates

First Submitted

October 7, 2019

First Submitted That Met QC Criteria

October 7, 2019

First Posted (Actual)

October 9, 2019

Study Record Updates

Last Update Posted (Actual)

October 21, 2019

Last Update Submitted That Met QC Criteria

October 17, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe