PreDiabetesBUHSCKNCT05759442
Clinical Efficacy and Safety of Metformin Versus Apple Cider Vinegar (ACV) in Prediabetics
A study testing Metformin Hydrochloride (HCL) and Apple cider vinegar in people with PreDiabetes, run by Bahria University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 40 years
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Metformin Hydrochloride (HCL) and Apple cider vinegar
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 15 Jul 2023
- 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 17 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and Female
- 17-40 years age
- Body Mass index (BMI) overweight and obese
- FBS (100-125 mg/dl)
- HBA1c 5.7% to 6.4%
Who cannot join
- Concomitant medical problems as established diabetes, hepatic or renal insufficiencies etc.
- Known allergy or intolerance to metformin or apple cider vinegar
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Metformin Hydrochloride (HCL), Apple cider vinegar
- Keywords
- Prediabetes, Metformin HCl, Apple cider vinegar
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin Hydrochloride (HCL)Drug
Tab Metformin HCL 500mg twice per day aimed at improving glycemic indices in Prediabetics
Apple cider vinegarDietary supplement
Apple cider vinegar aimed at improving glycemic indices in Prediabetics
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Tablet Metformin HCl 500 mg per oral twice daily for 12 weeks Receives: Drug: Metformin Hydrochloride (HCL) |
| Apple cider vinegar | Active comparator | Apple Cider Vinegar 15ml per day diluted in 200 ml of water for 12 weeks Receives: Dietary Supplement: Apple cider vinegar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Hemoglobin
Change in glycosylated hemoglobin (HbA1c ) in percent
Measured: 12 weeks
Fasting Blood Sugar
Change in fasting blood sugar (FBS) in mg/dL
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 posted8 Mar 2023
- Study start1 Jan 2023
- Primary completion1 Apr 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies 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
- Model description
- Randomized, open label, prospective, clinical trial
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shizma Junejo, Bahria University
- Investigators
- Dr.Shizma Junejo, MBBS,MSc, Principal investigator, Bahria University Health Sciences Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759442
- Sponsor's protocol ID
- ERC 123/2022
- Acronym
- BUHSCK
- Status last verified
- Aug 2023
- First submitted
- 18 Feb 2023
- Last updated
- 28 Aug 2023
- 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 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Metformin Versus Apple Cider Vinegar (ACV) in Prediabetics
- ClinicalTrials.gov ID
- NCT05759442
- Acronym / sponsor ID
- BUHSCK / ERC 123/2022
- Conditions
- PreDiabetes
- Keywords
- Prediabetes, Metformin HCl, Apple cider vinegar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Bahria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 8 Mar 2023 (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.
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..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open label, prospective, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: Metformin Hydrochloride (HCL)Tablet Metformin HCl 500 mg per oral twice daily for 12 weeks |
| Apple cider vinegar | Active comparator | Dietary Supplement: Apple cider vinegarApple Cider Vinegar 15ml per day diluted in 200 ml of water for 12 weeks |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Males and Female
- 17-40 years age
- Body Mass index (BMI) overweight and obese
- FBS (100-125 mg/dl)
- HBA1c 5.7% to 6.4%
Key exclusion criteria (2 listed)
- Concomitant medical problems as established diabetes, hepatic or renal insufficiencies etc.
- Known allergy or intolerance to metformin or apple cider vinegar
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 Hydrochloride (HCL)Tab Metformin HCL 500mg twice per day aimed at improving glycemic indices in Prediabetics | Drug | Metformin |
| Apple cider vinegarApple cider vinegar aimed at improving glycemic indices in Prediabetics | Dietary supplement | Apple cider vinegar |
Primary outcome
Glycated Hemoglobin
Time frame: 12 weeks
Change in glycosylated hemoglobin (HbA1c ) in percent
Fasting Blood Sugar
Time frame: 12 weeks
Change in fasting blood sugar (FBS) in mg/dL
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 28 Aug 2023.
- 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.Shizma Junejo, MBBS,MSc principal investigator
Bahria University Health Sciences Campus
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 Hydrochloride (HCL) and Apple cider vinegar in people with PreDiabetes, run by Bahria 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 5 inclusion and 2 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 28 Aug 2023. 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?
Glycated Hemoglobin (time frame: 12 weeks). The study lists 2 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 28 Aug 2023.