NCT06164535

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

December 30, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

November 30, 2023

Last Update Submit

December 7, 2023

Conditions

Cognitive Impairment

Keywords

CognitiveDPP-4 inhibitorsDiabetesDepression

Outcome Measures

Primary Outcomes (4)

  • Serum Inflammatory mediators; TNF-α

    ELISA kits

    Before and post 6 month of treatment

  • MMSE score

    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

    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

    Before and post 6 month of treatment

Secondary Outcomes (3)

  • Serum Insulin

    Before and post 6 month of treatment

  • Serum fasting and 2-he post prandial glucose

    Before and post 6 month of treatment

  • HOMA-IR

    Before and post 6 month of treatment

Study Arms (3)

Control Group

PLACEBO COMPARATOR

35 patients will be given placebo (only adjust their drugs to control blood glucose level)

Drug: Control group

DPPI Group

EXPERIMENTAL

35 T2DM patients will be given DPP4Is once or twice daily

Drug: DPP-4 inhibitor group

DPPI + metformin group

EXPERIMENTAL

35 T2DM patients will be given DPP4Is + metformin once or twice daily

Drug: DPP-4 inhibitor + metformin group

Interventions

Control groupDRUG

35 T2DM patients will be given placebo (only adjust their drugs to control blood glucose level)

Control Group
DPP-4 inhibitor groupDRUG

35 T2DM patients will be given DPP-4 I once or twice daily

DPPI Group
DPP-4 inhibitor + metformin groupDRUG

35 T2DM patients will be given DPP-4 I + metformin once or twice daily

DPPI + metformin group

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University hospital

Minya, 82511, Egypt

Location

MeSH Terms

Conditions

Cognitive DysfunctionDiabetes MellitusDepression

Interventions

Control GroupsDipeptidyl-Peptidase IV Inhibitors

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsProtease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Central Study Contacts

Asmaa Elsayed

CONTACT

+201095727201asmaa.abdelfattah@pharm.sohag.edu.eg

Engy Wahsh

CONTACT

engywahsh@o6u.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
all patient information will be anonymized giving only corresponding numbers, which will be revealed by the PI after assessment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of clinical pharmacy

Study Record Dates

First Submitted

November 30, 2023

First Posted

December 11, 2023

Study Start

December 30, 2023

Primary Completion

June 30, 2024

Study Completion

July 15, 2024

Last Updated

December 11, 2023

Record last verified: 2023-12

Locations

EG(1)