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

NCT05759442 | Completed

• 1 other identifier: ERC 123/2022
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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..

Conditions

PreDiabetes

Keywords

Prediabetes; Metformin HCl; Apple cider vinegar

Outcome Measures

Primary Outcomes (2)

• Glycated Hemoglobin

  Change in glycosylated hemoglobin (HbA1c ) in percent

  12 weeks

• Fasting Blood Sugar

  Change in fasting blood sugar (FBS) in mg/dL

  12 weeks

Study Arms (2)

Metformin

ACTIVE COMPARATOR

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

Drug: Metformin Hydrochloride (HCL)

Apple cider vinegar

ACTIVE COMPARATOR

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

Dietary Supplement: Apple cider vinegar

Interventions

Metformin Hydrochloride (HCL) DRUG

Tab Metformin HCL 500mg twice per day aimed at improving glycemic indices in Prediabetics

Metformin

Apple cider vinegar DIETARY_SUPPLEMENT

Apple cider vinegar aimed at improving glycemic indices in Prediabetics

Apple cider vinegar

Eligibility Criteria

• Age: 17 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bahria University: lead

Study Sites (1)

Diabetologist Clinics (02)

Karachi, Pakistan

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Dr.Shizma Junejo, MBBS,MSc

  Bahria University Health Sciences Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer Pharmacology Department

Model Details: Randomized, open label, prospective, clinical trial

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: March 8, 2023
• Study Start: January 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: July 15, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)