Clinical Efficacy and Safety of Metformin Versus Apple Cider Vinegar (ACV) in Prediabetics (BUHSCK)

August 25, 2023 updated by: Dr. Shizma Junejo, Bahria University

The goal of this clinical trial is to compare efficacy and safety of metformin versus apple cider vinegar in prediabetics . The main question[s] it aims to answer are:

  • Efficacy of metformin versus apple cider vinegar in prediabetics
  • Safety of metformin versus apple cider vinegar in prediabetics

Researchers will compare group of prediabetics taking metformin with group of prediabetics taking apple cider vinegar to see if there is difference in safety and efficacy..

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

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
      • Karachi, Pakistan
        • Diabetologist Clinics (02)

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males and Female
  • 17-40 years age
  • Body Mass index (BMI) overweight and obese
  • FBS (100-125 mg/dl)
  • HBA1c 5.7% to 6.4%

Exclusion Criteria:

  • Concomitant medical problems as established diabetes, hepatic or renal insufficiencies etc.
  • Known allergy or intolerance to metformin or apple cider vinegar

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: Metformin
Tablet Metformin HCl 500 mg per oral twice daily for 12 weeks
Drug: Metformin Hydrochloride (HCL)
Tab Metformin HCL 500mg twice per day aimed at improving glycemic indices in Prediabetics
Active Comparator: Apple cider vinegar
Apple Cider Vinegar 15ml per day diluted in 200 ml of water for 12 weeks
Dietary supplement: Apple cider vinegar
Apple cider vinegar aimed at improving glycemic indices in Prediabetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated Hemoglobin
Time Frame: 12 weeks
Change in glycosylated hemoglobin (HbA1c ) in percent
12 weeks
Fasting Blood Sugar
Time Frame: 12 weeks
Change in fasting blood sugar (FBS) in mg/dL
12 weeks

Collaborators and Investigators

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

Sponsor

Bahria University

Investigators

  • Principal Investigator: Dr.Shizma Junejo, MBBS,MSc, Bahria University Health Sciences Campus

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)

January 1, 2023

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

July 15, 2023

Study Registration Dates

First Submitted

February 18, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERC 123/2022

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.

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