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

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: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Metformin Oral Tablet; Dietary supplement: Vinegar

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

• 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

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: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Anti-Infective Agents; Anti-Bacterial Agents; Metformin; Acetic Acid
• 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