Cognitive ImpairmentPhase 4NCT06164535
The Effects of DPPIs on Cognitive Function of Diabetic Patients
A Phase 4 study testing DPP-4 inhibitor group and DPP-4 inhibitor + metformin group in people with Cognitive Impairment, run by Beni-Suef University at 1 site in Egypt.
Trial summary
This is a single-center, randomized controlled clinical trial with a parallel-group design conducted at Minia University hospital. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- DPP-4 inhibitor group and DPP-4 inhibitor + metformin group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2023to 15 Jul 2024
- Phase
- Phase 4
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Engy Wahsh contact
Egypt1 site
Minia University hospital
Minya, 82511
Asmaa Elsayed, +201095727201, asmaa.abdelfattah@pharm.sohag.edu.eg
Engy Wahsh, Ph.D.
About this study
Official title: 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.
Read the 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)
- Conditions
- Cognitive Impairment
- Being tested
- Control group, DPP-4 inhibitor group, DPP-4 inhibitor + metformin group
- Keywords
- Cognitive, DPP-4 inhibitors, Diabetes, Depression
- Medical subject headings
- Cognitive Dysfunction, Diabetes Mellitus, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupDrug
35 T2DM patients will be given placebo (only adjust their drugs to control blood glucose level)
DPP-4 inhibitor groupDrug
35 T2DM patients will be given DPP-4 I once or twice daily
DPP-4 inhibitor + metformin groupDrug
35 T2DM patients will be given DPP-4 I + metformin once or twice daily
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | 35 patients will be given placebo (only adjust their drugs to control blood glucose level) Receives: Drug: Control group |
| DPPI Group | Experimental | 35 T2DM patients will be given DPP4Is once or twice daily Receives: Drug: DPP-4 inhibitor group |
| DPPI + metformin group | Experimental | 35 T2DM patients will be given DPP4Is + metformin once or twice daily Receives: Drug: DPP-4 inhibitor + metformin group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Inflammatory mediators; TNF-α
ELISA kits
Measured: 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
Measured: 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.;
Measured: Before and post 6 month of treatment
serum amyloid-β
Measured: Before and post 6 month of treatment
Secondary outcomes (3)
Serum Insulin
ElISA kits
Measured: Before and post 6 month of treatment
Serum fasting and 2-he post prandial glucose
Measured: Before and post 6 month of treatment
HOMA-IR
Measured: Before and post 6 month of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start30 Dec 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- October 6 University, Minia University
- Responsible party
- Principal investigator, Asmaa Abdelfattah Elsayed, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164535
- Sponsor's protocol ID
- BeniSuefU2023
- Status last verified
- Dec 2023
- First submitted
- 30 Nov 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Some Antihyperglycemic Drugs on Cognitive Function and Risk of Depression of Diabetic Patients
- ClinicalTrials.gov ID
- NCT06164535
- Acronym / sponsor ID
- BeniSuefU2023
- Conditions
- Cognitive Impairment
- Keywords
- Cognitive, DPP-4 inhibitors, Diabetes, Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- October 6 University, Minia University
- Study start
- 30 Dec 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 11 Dec 2023 (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.
This is a single-center, randomized controlled clinical trial with a parallel-group design conducted at Minia University hospital.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: Control group35 patients will be given placebo (only adjust their drugs to control blood glucose level) |
| DPPI Group | Experimental | Drug: DPP-4 inhibitor group35 T2DM patients will be given DPP4Is once or twice daily |
| DPPI + metformin group | Experimental | Drug: DPP-4 inhibitor + metformin group35 T2DM patients will be given DPP4Is + metformin once or twice daily |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Control group35 T2DM patients will be given placebo (only adjust their drugs to control blood glucose level) | Drug | Control Group |
| DPP-4 inhibitor group35 T2DM patients will be given DPP-4 I once or twice daily | Drug | DPPI Group |
| DPP-4 inhibitor + metformin group35 T2DM patients will be given DPP-4 I + metformin once or twice daily | Drug | DPPI + metformin group |
Primary outcome
Serum Inflammatory mediators; TNF-α
Time frame: Before and post 6 month of treatment
ELISA kits
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
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.;
serum amyloid-β
Time frame: Before and post 6 month of treatment
3 secondary outcomes
Serum Insulin
Time frame: Before and post 6 month of treatment
Serum fasting and 2-he post prandial glucose
Time frame: Before and post 6 month of treatment
HOMA-IR
Time frame: Before and post 6 month of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
Engy Wahsh contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DPP-4 inhibitor group and DPP-4 inhibitor + metformin group in people with Cognitive Impairment, run by Beni-Suef University at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 11 Dec 2023. 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Elsayed (+201095727201, asmaa.abdelfattah@pharm.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Inflammatory mediators; TNF-α (time frame: Before and post 6 month of treatment). The study lists 4 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 11 Dec 2023.