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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Metformin Oral Tablet; Dietary Supplement: Vinegar

• Registration Number: NCT04120259
• Lead Sponsor: Ziauddin University

Brief Summary

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

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 Timeline

• Study Start: 2019-04-22
• Primary Completion: 2019-08-26
• Study Completion: 2019-08-26
• Status Verified: 2019-10
• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-09
• Last Update Submitted: 2019-10-17
• Last Update Posted: 2019-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Metformin Oral Tablet	Intervention: Metformin Tablet oral 750 mg OD
Group 2	Metformin Oral Tablet	Intervention: Metformin 750 mg oral plus 2 tablespoons of apple cider vinegar OD
Group 2	Vinegar	Intervention: Metformin 750 mg oral plus 2 tablespoons of apple cider vinegar OD

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ziauddin University; 🇵🇰 Karachi, Sindh, Pakistan