Diabetes Mellitus, Type 2NCT04120259
Effect of Apple Cider Vinegar and Metformin Combination vs Metformin Alone in Type 2 Diabetics
A study testing Metformin Oral Tablet and Vinegar in people with Diabetes Mellitus, Type 2, run by Ziauddin University at 1 site in Pakistan.
Trial summary
'This study aims to compare the effect of Metformin alone vs Metformin plus Apple Cider Vinegar in newly diagnosed Type 2 Diabetic Patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Metformin Oral Tablet and Vinegar
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Apr 2019to 26 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Metformin Oral Tablet, Vinegar
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Intervention: Metformin Tablet oral 750 mg OD Receives: Drug: Metformin Oral Tablet |
| Group 2 | Experimental | Intervention: Metformin 750 mg oral plus 2 tablespoons of apple cider vinegar OD Receives: Drug: Metformin Oral Tablet; Dietary Supplement: Vinegar |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI (Anthropometric Measurement)
Body Mass Index: A measure of obesity calculated as weight in kilograms divided by height in meters square
Measured: 12 weeks
Measurement of Hemoglobin A1c
A blood test for Glycated Hemoglobin that represents a 2-3 month glycemic control
Measured: 12 weeks
Measurement of Fasting Blood Sugar
A blood test that involves the measurement of plasma glucose after 8 to 12 hours of fasting
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start22 Apr 2019
- Primary completion26 Aug 2019
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Momina Abid, Ziauddin University
- Investigators
- Dr Momina Abid, MBBS,M Phil (ongoing), Principal investigator, Ziauddin UniversityDr Zahida Memon, MBBS,M Phil,PhD, Principal investigator, Ziauddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120259
- Sponsor's protocol ID
- 002
- Status last verified
- Oct 2019
- First submitted
- 7 Oct 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Apple Cider Vinegar and Metformin Combination vs Metformin Alone in Type 2 Diabetics:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04120259
- Acronym / sponsor ID
- 002
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
'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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Metformin Oral TabletIntervention: Metformin Tablet oral 750 mg OD |
| Group 2 | Experimental | Drug: Metformin Oral Tablet, Dietary Supplement: VinegarIntervention: Metformin 750 mg oral plus 2 tablespoons of apple cider vinegar OD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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%
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin Oral TabletA biguanide drug used as a first line therapy for Diabetes MellitusType 2 | Drug | Group 1, Group 2 |
| VinegarA common herbal/dietary supplement used for centuries as an anti bacterial, cleaning,cooking, anti diabetic agent, to name a few uses. | Dietary supplement | Group 2 |
Primary outcome
BMI (Anthropometric Measurement)
Time frame: 12 weeks
Body Mass Index: A measure of obesity calculated as weight in kilograms divided by height in meters square
Measurement of Hemoglobin A1c
Time frame: 12 weeks
A blood test for Glycated Hemoglobin that represents a 2-3 month glycemic control
Measurement of Fasting Blood Sugar
Time frame: 12 weeks
A blood test that involves the measurement of plasma glucose after 8 to 12 hours of fasting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Momina Abid, MBBS,M Phil (ongoing) principal investigator
Ziauddin University
Dr Zahida Memon, MBBS,M Phil,PhD principal investigator
Ziauddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin Oral Tablet and Vinegar in people with Diabetes Mellitus, Type 2, run by Ziauddin University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (Anthropometric Measurement) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.