Metformin, PrediabetesNCT07302932
Metformin and Molecular Aging in Prediabetes
A study testing Metformin treatment and Analyzed by qPCR for T/S ratio. in people with Metformin, Prediabetes, run by Diabetes Foundation, India at 1 site in India.
Trial summary
The incidence and prevalence of type 2 diabetes mellitus (T2DM) are increasing globally. The global prevalence of diabetes has nearly doubled since 1980, rising from 4.7% to 8.5% in the adult population. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Metformin, Prediabetes
- What is being tested?
- Metformin treatment and Analyzed by qPCR for T/S ratio.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2023to 30 Jan 2025
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 30-60 years Both genders (male and female)
- Diagnosis of pre-diabetes, defined as:
- Impaired Fasting Glucose (IFG): Fasting plasma glucose 100-125 mg/dL AND/OR Impaired Glucose Tolerance (IGT): 2-hour plasma glucose 140-199 mg/dL after 75 g oral glucose tolerance test (OGTT)
- IGT is mandatory (i.e., every participant must have IGT, even if IFG is also present)
Who cannot join
- Type 1 diabetes mellitus Type 2 diabetes mellitus Pregnancy or lactation Hypoglycemia (blood glucose <70 mg/dL) after medication Acute or chronic inflammatory diseases Immunological diseases (e.g., autoimmune diseases) History of organ transplantation Current or recent steroid therapy Uncontrolled arterial hypertension Known allergy or intolerance to metformin Major surgery or cardiovascular events (e.g., myocardial infarction, stroke) within the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Metformin Treatment on Surrogate Markers of Ageing (Leukocyte Telomere Length and Telomerase Activity), Longevity Gene Expression (Sirtuin 1, p66Shc, p53, Andmammalian Target of Rapamycin ), in North Indian Individuals With the Prediabetes: A Randomized Control Trial
The incidence and prevalence of type 2 diabetes mellitus (T2DM) are increasing globally. The global prevalence of diabetes has nearly doubled since 1980, rising from 4.7% to 8.5% in the adult population. Asian Indians have one of the highest incidence rates of pre-diabetes (10.3%) and type 2 diabetes mellitus (T2DM) (8.8%) among all major ethnic groups, and the conversion from pre-diabetes to diabetes occurs more rapidly in this population.
Metformin has been shown to effectively prevent the progression of prediabetes to overt diabetes. Furthermore, metformin improves lifespan in animal models through an anti-ageing pathway driven by mTOR. Metformin has also been shown to protect endothelial cells from hyperglycaemic damage by directly stimulating the expression of Sirtuin-1 (SIRT1), a deacetylase involved in metabolism and longevity by modulating SIRT1 downstream targets FoxO1 and p53/p21. It is important to note thatSIRT1, andmammalian target of rapamycin (mTOR) form a network that connects cellular metabolism and longevity programmes.
Read more
Only one study is available which has explored the relationship of metformin with longevity. Previous study conducted a single-blind randomized placebo-controlled trial in prediabetic subjects in Italy (n, 38) who received metformin 1500mg/day (n, 19) or placebo (n, 19) for 2 months. They demonstrated that metformin use significantly increased insulin sensitivity and metabolic parameters, SIRT1 gene/protein expression, and SIRT1 promoter chromatin accessibility. They also demonstrated that metformin use increased mTOR gene expression with a concurrent decrease in p70S6K phosphorylation and altered the plasma N-glycan profile. These authors concluded that in individuals with prediabetes, metformin ameliorated effector pathways that have been shown to regulate longevity in animal models.
The investigators recently did a study on 797 prediabetic women from north India (492 of whom were obese). In this study the investigators reported that age, obesity, and subcutaneous adiposity (predominantly truncal) are the main causes of leukocyte telomere shortening. It is yet unknown how metformin impacts aging-related genes and surrogate markers of ageing in the Asian Indian population.
This clinical trial aims to evaluate the effects of metformin treatment on surrogate markers of ageing (leukocyte telomere length and telomerase activity), in the setting of pre-diabetes. We intend to compare treatment with metformin for six months, versus placebo in pre-diabetic subjects. We will assess the surrogate markers of ageing (leukocyte telomere length and telomerase activity) and the expression of longevity genes SIRT1, p66Shc, p53 and mTOR in peripheral blood mononuclear cells (PBMCs) before and after 6 months of metformin treatment.
Read the detailed description
Research methodology and outcomes measures:
- Clinical History and Examination: Clinical history and blood pressure.
- Body mass Index: BMI will be calculated by using formula weight (Kg)/height (m2).
- Anthropometric Assessment: All circumferences (waist, hip, mid-thigh, mid arm and neck) and skinfolds (biceps, triceps, anterior axillary, subscapular, suprailiac, lateral thoracic and thigh) measurements will be taken. All the measurements will be repeated three times at same position and conditions.
- Body Composition: Body composition will be measured through multi-frequency bioelectrical impedance (MF-BIA; InBody 770, Cerritos, CA, USA) Visit-2 (Day 90) Visit-3 (Day 180) Compliance check Enrolment of prediabetes subjects (BMI>25kg/m2) (n=112) Investigations: Fasting blood glucose, IGT (2h post-oral glucose load (75g) and HBA1c Group-I: Metformin Group (n=56) Group-II: Placebo Group (n=56) Final Analysis Measurements same as in visit 1 Baseline investigations: Clinical and dietary profiles, blood pressure, anthropometric assessments [body mass index, circumferences (waist, hip, mid-thigh, mid-arm and neck) and skinfolds (biceps, triceps, sub scapular, suprailiac, thigh, lateral thoracic and calf)], body fat, handgrip muscle strength, glycemic and lipid profile other metabolic parameters, fasting serum insulin, C-peptide and HOMA-IR,leukocyte telomerase length and telomerase activity and gene expression of SIRT1, mTOR, p53, p66Shc genes. Randomization: Visit 1 (Day 0) Screening Diet and exercise (run in two weeks) 5
- Handgrip Muscle Strength: Grip strength will be measured using a Jamar Analogue Hand Dynamometer with participants seated, their elbow by their side and flexed to right angles, and a neutral wrist position, the dynamometer handle position II and provision of support underneath the dynamometer.
- Biochemical measurements: The blood sample shall be drawn after 12 hours overnight fast, subject having taken normal diet in the previous three days. A 75-g OGTT will be performed. Blood samples shall be analyzed for following; blood glucose, A1C, lipids, fasting insulin, C-peptide, Homeostasis Model Assessment (HOMA)- Insulin Resistance (IR), and HOMA- Beta (ß%) and serum glucagon levels.
- DNA Isolation and Quantification: DNA will be separated from peripheral blood mononuclear cells using the QIAamp DNA extraction kit (Qiagen, Hilden, Germany) and will be stored at -20oC for future experiments. After DNA isolation, the DNA samples will be quantified and diluted to 50 ng/μL. The concentration and quality of DNA will be both measured by using a nanodrop (Nanodrop Technologies, Wilmington, NC, USA) and samples will be included for analysis all will have an optical density ratio A 260/A280> 1.8. h) Measurement of Leukocyte Telomere Length: LTL will be analysed with a quantitative polymerase chain reaction (qPCR) based technique that compares telomere repeat sequence copy number (T) to a reference single copy-gene copy number (S). The telomere length for each sample will be estimated using the telomere to single copy gene ratio (T/S ratio) with the calculation of ΔCt [Ct (telomere)/Ct(single gene)]. T/S ratio for each sample (x) will be normalized to the mean T/S ratio of the reference sample [2-(ΔCtx-ΔCtr) = 2-ΔΔCt], which will be used for the standard curve, both as a reference sample and as a validation sample.
- Gene expression by real-time PCR: Total RNA will be extracted using aRNeasy Mini Kit, (QIAGEN) cDNA and synthesized with an iScript cDNA synthesis kit (Bio-Rad, USA). Q-PCR assay will be performed in a Thermal Cycler (iCycler iQ5, Bio-Rad, Hercules, CA). Primers for Sirt1, p66Shc, p53, and mTORwill be designed from sequences derived from the GenBank database using Primer 3 (Whitehead Institute, Massachusetts, USA) and Operon's Oligo software (Operon, California, USA), purchased from Eurofins MWG (Ebersberg, Germany). The comparative threshold cycle method (ΔΔCq), which compares differences in the threshold cycle values between groups, will be used to obtain the relative fold change of gene expression.
- Conditions
- Metformin, Prediabetes
- Being tested
- Metformin treatment, Analyzed by qPCR for T/S ratio.
- 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 treatmentDrug
Also called Placebo
A computer-generated randomization sequence will be created by an independent statistician using an unrestricted scheme. Allocation will be concealed in serially numbered, sealed, opaque envelopes held by non-study office staff.
After a two-week diet and exercise run-in period, subjects will be randomized to receive either metformin (500mg twice daily) or placebo for six months. Participants will monitor fasting and postprandial blood glucose monthly at home. Medication adherence will be tracked through daily diaries and pill counts at three-month visits.
Compliance (target ≥85%) will be maintained through biweekly phone calls (urban areas), bi-monthly home visits by health workers (rural areas), and three-monthly motivational sessions.
Analyzed by qPCR for T/S ratio.Drug
Analyzed by qPCR for T/S ratio.
| Study group | Role | What they receive |
|---|---|---|
| placebo for six months | Experimental | Following a two-week diet and exercise run-in period, subjects will be randomized to receive either metformin (500mg twice daily after meals) or matching placebo for six months. All participants will monitor fasting and postprandial blood glucose (post-breakfast, post-lunch, post-dinner) monthly at home using a glucose meter. Both groups will maintain daily diaries recording tablet consumption and any missed doses. A three-month medication supply will be provided at each visit, with leftover tablets counted to assess compliance. Receives: Drug: Metformin treatment |
| Effect of metformin treatment on Leukocyte telomere length | Experimental | Analyzed by qPCR for T/S ratio. Receives: Drug: Metformin treatment; Drug: Analyzed by qPCR for T/S ratio. |
| To evaluate the effects of metformin treatment on telomerase activity | Experimental | Telomerase activity was done by ELISA Mathod Receives: Drug: Metformin treatment |
| Expression of longevity genes SIRT1, p66Shc, p53 and mTOR | Experimental | Investigators were assessed the expression of longevity genes SIRT1, p66Shc, p53 and mTOR in peripheral blood mononuclear cells (PBMCs) before and after 6 months of metformin treatment. Receives: Drug: Metformin treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukocyte telomerase length
Leukocyte Telomere Length Measurement: LTL was analyzed using quantitative polymerase chain reaction (qPCR), comparing telomere repeat sequence copy number (T) to a reference single-copy gene (S). Relative fold changes in gene expression will be determined using the comparative threshold cycle method (ΔΔCq), comparing differences in threshold cycle values between groups.
Measured: 06 months
Telomerase activity
Telomerase activity was done by ELISA method
Measured: 06 months
Secondary outcomes (1)
Expression of longevity genes SIRT1, p66Shc, p53 and mTOR
Total RNA will be extracted using aRNeasy Mini Kit, (QIAGEN) cDNA and synthesized with an iScript cDNA synthesis kit (Bio-Rad, USA). Q-PCR assay will be performed in a Thermal Cycler (iCycler iQ5, Bio-Rad, Hercules, CA). Primers for Sirt1, p66Shc, p53, and mTORwill be designed from sequences derived from the GenBank database using Primer 3 (Whitehead Institute, Massachusetts, USA) and Operon's Oligo software (Operon, California, USA), purchased from Eurofins MWG (Ebersberg, Germany). The comparative threshold cycle method (ΔΔCq), which compares differences in the threshold cycle values between groups, will be used to obtain the relative fold change of gene expression.
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Feb 2023
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metformin, 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
- This clinical trial aims to evaluate the effects of metformin treatment on surrogate markers of ageing (leukocyte telomere length and telomerase activity), in the setting of pre-diabetes. We intend to compare treatment with metformin for six months, versus placebo in pre-diabetic subjects. We will assess the surrogate markers of ageing (leukocyte telomere length and telomerase activity) and the expression of longevity genes SIRT1, p66Shc, p53 and mTOR in peripheral blood mononuclear cells (PBMCs) before and after 6 months of metformin treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabetes Foundation, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302932
- Sponsor's protocol ID
- 2.5/FCDOC/EC/HAO/2022-23
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Metformin Treatment on Surrogate Markers of Ageing (Leukocyte Telomere Length and Telomerase Activity), Longevity Gene Expression (Sirtuin 1, p66Shc, p53, Andmammalian Target of Rapamycin ), in North Indian Individuals With the Prediabetes: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07302932
- Acronym / sponsor ID
- 2.5/FCDOC/EC/HAO/2022-23
- Conditions
- Metformin, Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Diabetes Foundation, IndiaUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 24 Dec 2025 (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 incidence and prevalence of type 2 diabetes mellitus (T2DM) are increasing globally. The global prevalence of diabetes has nearly doubled since 1980, rising from 4.7% to 8.5% in the adult population. Asian Indians have one of the highest incidence rates of pre-diabetes (10.3%) and type 2 diabetes mellitus (T2DM) (8.8%) among all major ethnic groups, and the conversion from pre-diabetes to diabetes occurs more rapidly in this population.
Metformin has been shown to effectively prevent the progression of prediabetes to overt diabetes. Furthermore, metformin improves lifespan in animal models through an anti-ageing pathway driven by mTOR. Metformin has also been shown to protect endothelial cells from hyperglycaemic damage by directly stimulating the expression of Sirtuin-1 (SIRT1), a deacetylase involved in metabolism and longevity by modulating SIRT1 downstream targets FoxO1 and p53/p21. It is important to note thatSIRT1, andmammalian target of rapamycin (mTOR) form a network that connects cellular metabolism and longevity programmes.
Only one study is available which has explored the relationship of metformin with longevity. Previous study conducted a single-blind randomized placebo-controlled trial in prediabetic subjects in Italy (n, 38) who received metformin 1500mg/day (n, 19) or placebo (n, 19) for 2 months. They demonstrated that metformin use significantly increased insulin sensitivity and metabolic parameters, SIRT1 gene/protein expression, and SIRT1 promoter chromatin accessibility. They also demonstrated that metformin use increased mTOR gene expression with a concurrent decrease in p70S6K phosphorylation and altered the plasma N-glycan profile. These authors concluded that in individuals with prediabetes, metformin ameliorated effector pathways that have been shown to regulate longevity in animal models.
The investigators recently did a study on 797 prediabetic women from north India (492 of whom were obese). In this study the investigators reported that age, obesity, and subcutaneous adiposity (predominantly truncal) are the main causes of leukocyte telomere shortening. It is yet unknown how metformin impacts aging-related genes and surrogate markers of ageing in the Asian Indian population.
This clinical trial aims to evaluate the effects of metformin treatment on surrogate markers of ageing (leukocyte telomere length and telomerase activity), in the setting of pre-diabetes. We intend to compare treatment with metformin for six months, versus placebo in pre-diabetic subjects. We will assess the surrogate markers of ageing (leukocyte telomere length and telomerase activity) and the expression of longevity genes SIRT1, p66Shc, p53 and mTOR in peripheral blood mononuclear cells (PBMCs) before and after 6 months of metformin treatment.
Detailed description
Research methodology and outcomes measures:
- Clinical History and Examination: Clinical history and blood pressure.
- Body mass Index: BMI will be calculated by using formula weight (Kg)/height (m2).
- Anthropometric Assessment: All circumferences (waist, hip, mid-thigh, mid arm and neck) and skinfolds (biceps, triceps, anterior axillary, subscapular, suprailiac, lateral thoracic and thigh) measurements will be taken. All the measurements will be repeated three times at same position and conditions.
- Body Composition: Body composition will be measured through multi-frequency bioelectrical impedance (MF-BIA; InBody 770, Cerritos, CA, USA) Visit-2 (Day 90) Visit-3 (Day 180) Compliance check Enrolment of prediabetes subjects (BMI>25kg/m2) (n=112) Investigations: Fasting blood glucose, IGT (2h post-oral glucose load (75g) and HBA1c Group-I: Metformin Group (n=56) Group-II: Placebo Group (n=56) Final Analysis Measurements same as in visit 1 Baseline investigations: Clinical and dietary profiles, blood pressure, anthropometric assessments [body mass index, circumferences (waist, hip, mid-thigh, mid-arm and neck) and skinfolds (biceps, triceps, sub scapular, suprailiac, thigh, lateral thoracic and calf)], body fat, handgrip muscle strength, glycemic and lipid profile other metabolic parameters, fasting serum insulin, C-peptide and HOMA-IR,leukocyte telomerase length and telomerase activity and gene expression of SIRT1, mTOR, p53, p66Shc genes. Randomization: Visit 1 (Day 0) Screening Diet and exercise (run in two weeks) 5
- Handgrip Muscle Strength: Grip strength will be measured using a Jamar Analogue Hand Dynamometer with participants seated, their elbow by their side and flexed to right angles, and a neutral wrist position, the dynamometer handle position II and provision of support underneath the dynamometer.
- Biochemical measurements: The blood sample shall be drawn after 12 hours overnight fast, subject having taken normal diet in the previous three days. A 75-g OGTT will be performed. Blood samples shall be analyzed for following; blood glucose, A1C, lipids, fasting insulin, C-peptide, Homeostasis Model Assessment (HOMA)- Insulin Resistance (IR), and HOMA- Beta (ß%) and serum glucagon levels.
- DNA Isolation and Quantification: DNA will be separated from peripheral blood mononuclear cells using the QIAamp DNA extraction kit (Qiagen, Hilden, Germany) and will be stored at -20oC for future experiments. After DNA isolation, the DNA samples will be quantified and diluted to 50 ng/μL. The concentration and quality of DNA will be both measured by using a nanodrop (Nanodrop Technologies, Wilmington, NC, USA) and samples will be included for analysis all will have an optical density ratio A 260/A280> 1.8. h) Measurement of Leukocyte Telomere Length: LTL will be analysed with a quantitative polymerase chain reaction (qPCR) based technique that compares telomere repeat sequence copy number (T) to a reference single copy-gene copy number (S). The telomere length for each sample will be estimated using the telomere to single copy gene ratio (T/S ratio) with the calculation of ΔCt [Ct (telomere)/Ct(single gene)]. T/S ratio for each sample (x) will be normalized to the mean T/S ratio of the reference sample [2-(ΔCtx-ΔCtr) = 2-ΔΔCt], which will be used for the standard curve, both as a reference sample and as a validation sample.
- Gene expression by real-time PCR: Total RNA will be extracted using aRNeasy Mini Kit, (QIAGEN) cDNA and synthesized with an iScript cDNA synthesis kit (Bio-Rad, USA). Q-PCR assay will be performed in a Thermal Cycler (iCycler iQ5, Bio-Rad, Hercules, CA). Primers for Sirt1, p66Shc, p53, and mTORwill be designed from sequences derived from the GenBank database using Primer 3 (Whitehead Institute, Massachusetts, USA) and Operon's Oligo software (Operon, California, USA), purchased from Eurofins MWG (Ebersberg, Germany). The comparative threshold cycle method (ΔΔCq), which compares differences in the threshold cycle values between groups, will be used to obtain the relative fold change of gene expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- This clinical trial aims to evaluate the effects of metformin treatment on surrogate markers of ageing (leukocyte telomere length and telomerase activity), in the setting of pre-diabetes. We intend to compare treatment with metformin for six months, versus placebo in pre-diabetic subjects. We will assess the surrogate markers of ageing (leukocyte telomere length and telomerase activity) and the expression of longevity genes SIRT1, p66Shc, p53 and mTOR in peripheral blood mononuclear cells (PBMCs) before and after 6 months of metformin treatment.
| Arm | Type | Receives |
|---|---|---|
| placebo for six months | Experimental | Drug: Metformin treatmentFollowing a two-week diet and exercise run-in period, subjects will be randomized to receive either metformin (500mg twice daily after meals) or matching placebo for six months. All participants will monitor fasting and postprandial blood glucose (post-breakfast, post-lunch, post-dinner) monthly at home using a glucose meter. Both groups will maintain daily diaries recording tablet consumption and any missed doses. A three-month medication supply will be provided at each visit, with leftover tablets counted to assess compliance. |
| Effect of metformin treatment on Leukocyte telomere length | Experimental | Drug: Metformin treatment, Drug: Analyzed by qPCR for T/S ratio.Analyzed by qPCR for T/S ratio. |
| To evaluate the effects of metformin treatment on telomerase activity | Experimental | Drug: Metformin treatmentTelomerase activity was done by ELISA Mathod |
| Expression of longevity genes SIRT1, p66Shc, p53 and mTOR | Experimental | Drug: Metformin treatmentInvestigators were assessed the expression of longevity genes SIRT1, p66Shc, p53 and mTOR in peripheral blood mononuclear cells (PBMCs) before and after 6 months of metformin treatment. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 30-60 years Both genders (male and female)
- Impaired Fasting Glucose (IFG): Fasting plasma glucose 100-125 mg/dL AND/OR Impaired Glucose Tolerance (IGT): 2-hour plasma glucose 140-199 mg/dL after 75 g oral glucose tolerance test (OGTT)
- IGT is mandatory (i.e., every participant must have IGT, even if IFG is also present)
Key exclusion criteria (1 listed)
- Type 1 diabetes mellitus Type 2 diabetes mellitus Pregnancy or lactation Hypoglycemia (blood glucose <70 mg/dL) after medication Acute or chronic inflammatory diseases Immunological diseases (e.g., autoimmune diseases) History of organ transplantation Current or recent steroid therapy Uncontrolled arterial hypertension Known allergy or intolerance to metformin Major surgery or cardiovascular events (e.g., myocardial infarction, stroke) within the last 3 months
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 treatmentAlso: PlaceboA computer-generated randomization sequence will be created by an independent statistician using an unrestricted scheme. Allocation will be concealed in serially numbered, sealed, opaque envelopes held by non-study office staff. After a two-week diet and exercise run-in period, subjects will be randomized to receive either metformin (500mg twice daily) or placebo for six months. Participants will monitor fasting and postprandial blood glucose monthly at home. Medication adherence will be tracked through daily diaries and pill counts at three-month visits. Compliance (target ≥85%) will be maintained through biweekly phone calls (urban areas), bi-monthly home visits by health workers (rural areas), and three-monthly motivational sessions. | Drug | Effect of metformin treatment on Leukocyte telomere length, Expression of longevity genes SIRT1, p66Shc, p53 and mTOR, To evaluate the effects of metformin treatment on telomerase activity, placebo for six months |
| Analyzed by qPCR for T/S ratio.Analyzed by qPCR for T/S ratio. | Drug | Effect of metformin treatment on Leukocyte telomere length |
Primary outcome
Leukocyte telomerase length
Time frame: 06 months
Leukocyte Telomere Length Measurement: LTL was analyzed using quantitative polymerase chain reaction (qPCR), comparing telomere repeat sequence copy number (T) to a reference single-copy gene (S). Relative fold changes in gene expression will be determined using the comparative threshold cycle method (ΔΔCq), comparing differences in threshold cycle values between groups.
Telomerase activity
Time frame: 06 months
Telomerase activity was done by ELISA method
1 secondary outcome
Expression of longevity genes SIRT1, p66Shc, p53 and mTOR
Time frame: 6 MONTHS
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 24 Dec 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 treatment and Analyzed by qPCR for T/S ratio. in people with Metformin, Prediabetes, run by Diabetes Foundation, India at 1 site in India.
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 4 inclusion and 1 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 24 Dec 2025. 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 India. 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?
Leukocyte telomerase length (time frame: 06 months). 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 24 Dec 2025.