Clinical Efficacy and Safety of Metformin Versus Apple Ci... | NCT05759442

Studies
Clinical Efficacy and Safety of Metformin Versus Apple Cider Vinegar (ACV) in Prediabetics

NCT05759442

Sponsor

Bahria University

Status

Completed

Last Update Posted

Aug 28, 2023Actual

Enrollment

46Actual

Phase

Not Applicable

Conditions

PreDiabetes

Interventions

Metformin Hydrochloride (HCL)
Apple cider vinegar

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Apr 1, 2023Actual

Completion Date

Jul 15, 2023Actual

First Submitted Date

Feb 18, 2023

First Submission Date that Met QC Criteria

Mar 6, 2023

First Posted Date

Mar 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2023

Last Update Posted Date

Aug 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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 compare group of prediabetics taking metformin with group of prediabetics taking apple cider vinegar to see if there is difference in safety and efficacy..

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metformin	Active Comparator	Tablet Metformin HCl 500 mg per oral twice daily for 12 weeks	Drug: Metformin Hydrochloride (HCL)
Apple cider vinegar	Active Comparator	Apple Cider Vinegar 15ml per day diluted in 200 ml of water for 12 weeks	Dietary Supplement: Apple cider vinegar

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metformin Hydrochloride (HCL)	Drug	Tab Metformin HCL 500mg twice per day aimed at improving glycemic indices in Prediabetics	Metformin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glycated Hemoglobin	Change in glycosylated hemoglobin (HbA1c ) in percent	12 weeks
Fasting Blood Sugar	Change in fasting blood sugar (FBS) in mg/dL	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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%

Exclusion Criteria:

Concomitant medical problems as established diabetes, hepatic or renal insufficiencies etc.
Known allergy or intolerance to metformin or apple cider vinegar

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr.Shizma Junejo, MBBS,MSc	Bahria University Health Sciences Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Diabetologist Clinics (02)		Karachi			Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011236	Prediabetic State

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided