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

Primary Purpose

PreDiabetes

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Metformin Hydrochloride (HCL)
Apple cider vinegar
Sponsored by
Bahria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PreDiabetes focused on measuring Prediabetes, Metformin HCl, Apple cider vinegar

Eligibility Criteria

17 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Diabetologist Clinics (02)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Metformin

Apple cider vinegar

Arm Description

Tablet Metformin HCl 500 mg per oral twice daily for 12 weeks

Apple Cider Vinegar 15ml per day diluted in 200 ml of water for 12 weeks

Outcomes

Primary Outcome Measures

Glycated Hemoglobin
Change in glycosylated hemoglobin (HbA1c ) in percent
Fasting Blood Sugar
Change in fasting blood sugar (FBS) in mg/dL

Secondary Outcome Measures

Full Information

First Posted
February 18, 2023
Last Updated
August 25, 2023
Sponsor
Bahria University
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1. Study Identification

Unique Protocol Identification Number
NCT05759442
Brief Title
Clinical Efficacy and Safety of Metformin Versus Apple Cider Vinegar (ACV) in Prediabetics
Acronym
BUHSCK
Official Title
Clinical Efficacy and Safety of Metformin Versus Apple Cider Vinegar (ACV) in Prediabetics
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
July 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahria University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
Keywords
Prediabetes, Metformin HCl, Apple cider vinegar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, open label, prospective, clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
Tablet Metformin HCl 500 mg per oral twice daily for 12 weeks
Arm Title
Apple cider vinegar
Arm Type
Active Comparator
Arm Description
Apple Cider Vinegar 15ml per day diluted in 200 ml of water for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Metformin Hydrochloride (HCL)
Intervention Description
Tab Metformin HCL 500mg twice per day aimed at improving glycemic indices in Prediabetics
Intervention Type
Dietary Supplement
Intervention Name(s)
Apple cider vinegar
Intervention Description
Apple cider vinegar aimed at improving glycemic indices in Prediabetics
Primary Outcome Measure Information:
Title
Glycated Hemoglobin
Description
Change in glycosylated hemoglobin (HbA1c ) in percent
Time Frame
12 weeks
Title
Fasting Blood Sugar
Description
Change in fasting blood sugar (FBS) in mg/dL
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.Shizma Junejo, MBBS,MSc
Organizational Affiliation
Bahria University Health Sciences Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetologist Clinics (02)
City
Karachi
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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