Type 1 diabetes mellitus Digestive System Type 1 diabetes mellitus
Conditions
Interventions
At baseline, participants undergo a clinical examinations and provide blood samples to assess for HbA1c, fasting C-peptide (FCP) and 2hour-C-peptide (2h-CP) levels (as indirect measures of endogenous
Sponsors
Wadi EL-Neel hospital (JCI)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged between 2 to 30 years of age 2. Confirmed T1D based on the American Diabetes association (ADA) 2015 criteria for diagnosis 3. Body mass index (BMI) of = 29.9
Exclusion criteria
Exclusion criteria: 1. Active infections 2. Any chronic or acute illness 3. Antibodies to hepatitis B surface antigen 4. Hepatitis C 5. Human immunodeficiency virus or evidence of diabetic complications at baseline 6. Pregnant, are breast-feeding or intend to become pregnant during the study 7. Clinically relevant uncontrolled medical conditions not associated with diabetes (such as hematologic, renal, hepatic, neurologic, cardiac and respiratory conditions) 8. Evidence of active malignancy or a prior history of active malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety is measured using the morbidity, mortality, and unwanted side effects (through patient records) during the procedure and at 12 month follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serological changes in positive islet cell and insulin antibody levels are measured using blood samples at baseline and six months 2. ß-cell function is measured using blood samples( HbA1c and in FCP and 2h-CP levels) at baseline, month one-two, month three-five, month six-eight and months eight to 12 3. Abdominal pain and other clinical parameters are measured using clinical examination during the procedure and at month one-two, month three-five, month six-eight and month 12 | — |
Countries
Egypt
Outcome results
None listed