The Effects of DPPIs on Cognitive Function of Diabetic Patients

December 7, 2023 updated by: Asmaa Abdelfattah Elsayed, Beni-Suef University

The Effects of Some Antihyperglycemic Drugs on Cognitive Function and Risk of Depression of Diabetic Patients

This is a single-center, randomized controlled clinical trial with a parallel-group design conducted at Minia University hospital.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

All patients admitted to Diabetes clinics of Minia University Hospital, will be screened for the eligibility criteria.

diabetic patients (aged above 50 years) with uncontrolled diabetes on oral hypoglycemic drugs. 105 patients will be enrolled and randomized into three groups.

Group I=35 T2DM patients given DPP4Is Group II=35 T2DM patients given DPP4Is and metformin. Group III=35 patients will be given placebo (only adjust their drugs to control blood glucose level)

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Minya, Egypt, 82511
        • Minia university hospital
        • Contact:
        • Sub-Investigator:
          • Engy Wahsh, Ph.D.
        • Sub-Investigator:
          • Shireen Riad, Ph.D.
        • Sub-Investigator:
          • Asmaa Mohamed, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Type-2 diabetic adult subjects (above 50 years old) who had uncontrolled (A1c=8-9 %) blood glucose levels with an oral hypoglycemic drug at the screening visit were eligible to participate.

Exclusion Criteria:

Those with type1 diabetes or ketoacidosis, end organ failure as chronic renal failure (estimated serum creatinine level ≥ 1.5mg/dl in male and ≥ 1.4mg/dl in female), liver cell failure (elevated alanine transaminase (ALT) and aspartate transaminase (AST) ≥ 2 folds), and heart failure, previous history of pancreatitis, and pregnant or lactating females were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
35 patients will be given placebo (only adjust their drugs to control blood glucose level)
Drug: Control group
35 T2DM patients will be given placebo (only adjust their drugs to control blood glucose level)
Experimental: DPPI Group
35 T2DM patients will be given DPP4Is once or twice daily
Drug: DPP-4 inhibitor group
35 T2DM patients will be given DPP-4 I once or twice daily
Experimental: DPPI + metformin group
35 T2DM patients will be given DPP4Is + metformin once or twice daily
Drug: DPP-4 inhibitor + metformin group
35 T2DM patients will be given DPP-4 I + metformin once or twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Inflammatory mediators; TNF-α
Time Frame: Before and post 6 month of treatment
ELISA kits
Before and post 6 month of treatment
MMSE score
Time Frame: Before and post 6 month of treatment
Validated questionnaire assessing the Estimation of Mini Mental State The MMSE has a maximum score of 30 points. The scores are generally grouped as follows: 25-30 points: normal cognition 21-24 points: mild dementia 10-20 points: moderate dementia Examination (MMSE) score
Before and post 6 month of treatment
PHQ-9
Time Frame: Before and post 6 month of treatment
Validated questionnaire assessing patient mental health and depression PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression.;
Before and post 6 month of treatment
serum amyloid-β
Time Frame: Before and post 6 month of treatment
Before and post 6 month of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Insulin
Time Frame: Before and post 6 month of treatment
ElISA kits
Before and post 6 month of treatment
Serum fasting and 2-he post prandial glucose
Time Frame: Before and post 6 month of treatment
Before and post 6 month of treatment
HOMA-IR
Time Frame: Before and post 6 month of treatment
Before and post 6 month of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Collaborators

Faculty of Medicine, Minia University
Clinical Pharmacy Department, Faculty of Pharmacy, 6 October University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 30, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

July 15, 2024

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Estimated)

December 11, 2023

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeniSuefU2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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