NCT07083232

Brief Summary

The aim of the present study is to evaluate the prophylactic effect of Sitagliptin, Pioglitazone and Dapagliflozine on Isoprenaline induced myocardial infarction in type II diabetic rats.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2024

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
Last Updated

August 14, 2025

Status Verified

July 1, 2023

Enrollment Period

Same day

First QC Date

July 16, 2025

Last Update Submit

August 9, 2025

Conditions

Keywords

Myocardial InfarctionDiabeticRatsSitagliptinPioglitazoneDapagliflozine

Outcome Measures

Primary Outcomes (1)

  • blood glucose

    one week

Secondary Outcomes (1)

  • tumor necrosis factor-α

    One week

Study Arms (5)

standard normal diet and water group

PLACEBO COMPARATOR

Group I: formed of normal animals. They were allowed standard normal diet and water. They received no drugs.

Dietary Supplement: standard normal diet

low dose Streptozotocin group

EXPERIMENTAL

Group II: Non-treated diabetic rats; diabetes was induced by administration of 20% fructose solution in drinking water for 2 weeks, then intra peritoneal injection of a low dose STZ (40 mg/kg b.w.)

Drug: low dose Streptozotocin

Sitagliptin group

EXPERIMENTAL

Group III: Sitagliptin treated diabetic group sitagliptin was administered by gastric gavage in a dose 10mg/ kg /day for 4 weeks

Drug: Sitagliptin (Novartis, USA)

Pioglitazone group

EXPERIMENTAL

Group IV : Pioglitazone treated diabetic group ; Pioglitazone was administered by gastric gavage in a dose 10 mg/ kg /day for 4 weeks

Drug: Pioglitazone hydrochloride (Unipharma., Egypt)

Dapagliflozine group

EXPERIMENTAL

Group V : Dapagliflozine treated diabetic group (G5); Dapagliflozine was administered by gastric gavage in a dose 1mg/ kg /day for 4 weeks

Drug: Dapagliflozine hemihydrate (Janssen, USA)

Interventions

standard normal dietDIETARY_SUPPLEMENT

Group I: formed of normal animals. They were allowed standard normal diet and water. They received no drugs

standard normal diet and water group

Non-treated diabetic rats; diabetes was induced by administration of 20% fructose solution in drinking water for 2 weeks, then intra peritoneal injection of a low dose STZ (40 mg/kg b.w.), was done

low dose Streptozotocin group

Sitagliptin treated diabetic group sitagliptin was administered by gastric gavage in a dose 10mg/ kg /day for 4 weeks

Sitagliptin group

Pioglitazone treated diabetic group (G4); Pioglitazone was administered by gastric gavage in a dose 10 mg/ kg /day for 4 weeks

Pioglitazone group

Dapagliflozine treated diabetic group (G5); Dapagliflozine was administered by gastric gavage in a dose 1mg/ kg /day for 4 weeks

Dapagliflozine group

Eligibility Criteria

Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • adult male albino rats obtained from (Experimental Animal Breeding Farm, assuit -Cairo) weighing between 150- 200 g (at the beginning of the study)

You may not qualify if:

  • Female rats --Weight \>200g

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alazher University.assuit Branch

Asyut, Egypt

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

StreptozocinSitagliptin PhosphatelactitolPioglitazone

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsAminoglycosidesGlycosidesCarbohydratesTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesThiazolidinedionesThiazolesSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of pharmacology

Study Record Dates

First Submitted

July 16, 2025

First Posted

July 24, 2025

Study Start

October 30, 2024

Primary Completion

October 30, 2024

Study Completion

November 30, 2024

Last Updated

August 14, 2025

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations