Status:
COMPLETED
The Impact of Sitagliptin as an Add on Therapy With Closed Loop Control in Adolescents With Diabetic Nephropathy
Lead Sponsor:
Ain Shams University
Collaborating Sponsors:
Ahram Canadian University
Conditions:
Type 1 Diabetic Nephropathy
Eligibility:
All Genders
12-18 years
Phase:
PHASE3
Brief Summary
Diabetic nephropathy (DN) is one of the most frequent microvascular complications of diabetes mellitus, affecting 25 to 40% of patients with type 1 diabetes (T1DM). Early diagnosis, appropriate patien...
Detailed Description
Evidence from preclinical investigation suggests that DPP-4 inhibition may have beneficial effects on various metabolic indicators in diabetes. DPP-4 inhibitors, such as sitagliptin, have been widely ...
Eligibility Criteria
Inclusion
- T1DM patients aged 12-18 years with at least 5 years disease duration defined according to the criteria of International Society for Pediatric and Adolescent Diabetes (ISPAD) .
- Patients on insulin pump therapy using Medtronic advanced hybrid closed system (Medtronic, Northridge, USA) with Guardian™ 3 sensor or Guardian™ 4 sensor and Guardian link transmitter initiated at least 6 months before the study, patients with minimum daily insulin requirement of more than 8 units, willingness and ability to adhere to the study protocol, and access to the internet as well as a computer system that met requirements for uploading the study pump data.
- Active diabetic nephropathy in the form of microalbuminuria (urinary albumin excretion ) 30-299 mg/g creatinine in two of three samples over a 3- to 6-months period despite angiotensin converting enzyme inhibitors).
- Hemoglobin A1c (HbA1c) ≤8.5%.
- Patients on regular visits to clinic.
Exclusion
- patients with other diabetic microvascular complications (neuropathy or retinopathy) or with macrovascular complications.
- Patients with history of liver disease or any disorder likely to impair liver functions or elevated liver enzymes.
- Patients with any evidence of renal impairment due to causes other than diabetes.
- Patients with hypertension.
- Hepatitis virus infection (B or C) or any evidence of infection
- Participation in a previous investigational drug study within 3 months preceding screening.
- Hypoglycemic unawareness or recurrent severe hypoglycemic episodes in the last 6 months prior to recruitment.
- Recurrent diabetic ketoacidosis (DKA) (more than 2 episodes in the previous 6 months).
- Taking other oral hypoglycemic medications which could affect blood glucose.
- Patients with known allergy to sitagliptin.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06115460
Start Date
March 1 2022
End Date
June 15 2023
Last Update
November 7 2023
Active Locations (1)
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1
Nancy Elbarbary
Cairo, Egypt, 11361