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Status unknownNCT05429554Updated Jun 23, 2022

The Effect of Metformin and DPP4 Inhibitors on Cognition and Cardiovascular Protection in Type 2 Diabetic Patients

An observational study in Type 2 Diabetes Mellitus, sponsored by MTI University. Status unknown at 1 site in Egypt. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-06-23.

Sponsored by MTI University · Observational

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
40 Years to 60 Years
Sex
All
01

Study summary

The Impact of Metformin and Dipeptidyl Peptidase- 4 Inhibitors on Cognitive Function and cardiovascular protection in Type 2 Diabetic Patients

Read the detailed description

This study aims to investigate the effect of daily oral DPP4 inhibitors and oral metformin on neurodegeneration in type 2 diabetic patients.

This study aims to compare between the cardiovascular protective properties of DPP-4 inhibitors and Metformin in type 2 diabetic patients.

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 2

9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's planned enrollment of 60 is below the median of 300 across 1,622 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

MTI University is the lead sponsor of 61 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study contains 2 groups each group consists of 30 patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient should be diagnosed with Type 2 diabetes mellitus (T2DM) and guided with HA1c ≥7, age ≥40 years.
  • moderate hypertension.

Exclusion criteria

Exclusion Criteria:

    • Diabetic patients who have been currently receiving anti-diabetic agents other than metformin and/or insulin

      • Patients with type 1 DM, active liver disease, recent history of cardiovascular disease (acute coronary syndrome, coronary artery intervention, New York Heart Association Class III/IV heart failure, stroke, transient ischemic neurologic event, or new/worsening symptoms of coronary heart disease or cerebrovascular disease), severe peripheral vascular disease, triglyceride levels ≥ 600 mg/dL, history of HIV infection, pancreatitis, malignancy or clinically important hematologic disorder, and an estimated glomerular filtration rate (eGFR; calculated using the Modification of Diet in Renal Disease formula) less than 30 mL/min/1.73 m2.
      • Moreover, patients with dementia, AD, those were in delirium status during evaluation period, patients with psychotic disease (schizoaffective disorder, etc.)
      • Alcohol and substance addiction were not enrolled in the study.
      • Also, patients who have any hypersensitivity to metformin or to DPP4 inhibitors were also excluded.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • group 1

    patients will be treated with DPP4 inhibitor + metformin

    Drug: Vildagliptin

  • control

    patients will be treated with metformin without DPP4 inhibitor.

Interventions

  • DrugVildagliptin

    observe the effect of vildagliptin on cognitive function and cardiovascular in diabetic patients

06

What researchers measure

Primary outcomes

  1. improve the neurodegeneration and cardiovascular effect in diabetic patients

    improve the cognition and cardiovascular effect in type 2 diabetic patients

    Time frame: September 2022

07

Study locations

1 of 1 sites recruiting
  • National Institute of diabetes and endocrinology
    Cairo, Al Kasr Al Aini, Egypt
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2022; primary completion for Sep 2022, 3 months later.

Of 398 non-industry observational studies under Diabetes Mellitus, Type 2, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 89. This study's planned 3 months is below that.

Counting every sponsor, half of 562 studies reached it within 31 months; a quarter within 17 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 19, 2022
First posted
Jun 23, 2022
StartEst.
Jun 2022
Primary completionEst.
Sep 2022
CompletionEst.
Sep 2022
Last update
Jun 23, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05429554
Lead sponsor
MTI University
Collaborators
National Institute of Diabetes and Endocrinology, Egypt
Responsible party
Toka Hesham (Teaching assistant of Clinical Pharmacy, MTI University) — Principal investigator
First posted
Jun 23, 2022
Start date
Jun 2022 (estimated)
Primary completion
Sep 2022 (estimated)
Completion
Sep 2022 (estimated)
Last update
Jun 23, 2022

Study contacts

Toka H Elemary
Contact
tokahesham77@gmail.com
+01069155142
Dalia Zaafar
Contact
dalia.zaffar@pharm.mti.edu.eg
+01117922833
Toka Hesham
principal investigator · Bachelor of Pharmacy and Pharmaceutical sciences (Clinical Pharmacy)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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