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

N/ACompletedNCT04120259

Ziauddin University126 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

126

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin Oral TabletDRUG

A biguanide drug used as a first line therapy for Diabetes MellitusType 2

VinegarDIETARY_SUPPLEMENT

A common herbal/dietary supplement used for centuries as an anti bacterial, cleaning,cooking, anti diabetic agent, to name a few uses.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Ziauddin University

Karachi, Sindh, Pakistan

Outcomes

Primary Outcomes

BMI (Anthropometric Measurement)

Body Mass Index: A measure of obesity calculated as weight in kilograms divided by height in meters square

Time frame: 12 weeks

Measurement of Hemoglobin A1c

A blood test for Glycated Hemoglobin that represents a 2-3 month glycemic control

Time frame: 12 weeks

Measurement of Fasting Blood Sugar

A blood test that involves the measurement of plasma glucose after 8 to 12 hours of fasting

Time frame: 12 weeks

Data from ClinicalTrials.gov

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