Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes (NCT03746769) | Clinical Trial Compass
RecruitingPhase 1/2
Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes
United States20 participantsStarted 2019-07-07
Plain-language summary
This clinical study will evaluate the safety and effectiveness of Gastrin treatment with islet transplantation to help patients with difficult to control type 1 diabetes make insulin again and improve blood sugar control.
This study involves two investigational (experimental) products not yet approved by the U.S. Food and Drug Administration (FDA) as a treatment for any disease:
1. Human allogenic islet cells (islet cells from a deceased, unrelated human donor)
2. Gastrin-17 (Gastrin) - a hormone secreted by the gut
Who can participate
Age range18 Years – 68 Years
SexALL
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Inclusion criteria
✓. Age 18-68 years
✓. Type 1 diabetes mellitus (documented with fasting C-peptide level of \</= 0.2 ng/ml before and \</= 0.3 ng/ml after IV administration of 1 mg of glucagon) for at least 5 years.
✓. Unstable blood glucose characterized by:
✓and/or- Hypoglycemia unawareness (Clarke score of 4 or more).
✓and/or- One or more severe hypoglycemic episodes in 12 months preceding enrollment
✓and/or- Erratic blood glucose levels that interfere with daily activities
✓and/or- One or more hospital visits for diabetic ketoacidosis in the 12 months preceding enrollment
✓. Ability and willingness to comply with post-transplant regimen, including immunosuppression, use of reliable contraception, frequent clinic visits, testing and maintaining detailed logs of blood glucose levels, insulin doses and medications, and completing detailed follow-up studies.
Exclusion criteria
✕. BMI \> 33
✕. Insulin requirements \> 1.0 units/kg/day
✕. Significant kidney disease (estimated GFR from serum creatinine measurement \<65 ml/min, random spot urine microalbumin to creatinine ratio \>300mg albumin/g creatinine)
✕. Significant hepatobiliary disease, including elevation of liver enzymes \> twice the upper limit of normal for each of ALT and AST (any elevation of these enzymes will be determined), bilirubin not within normal limits, albumin \< 3.5 g/dl, liver masses, portal vein thrombosis, evidence of portal hypertension, or significant, untreated gallbladder disease (i.e. gallstones)
What they're measuring
1
Proportion of subjects who are insulin independent, free from severe hypoglycemia and have HbA1c less than or equal to 6.5% ("complete response")
Timeframe: 1 year post transplant (6 months after second course of Gastrin)
Trial details
NCT IDNCT03746769
SponsorCity of Hope Medical Center
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2028-08-01
Contact for this trial
Arthur Riggs Diabetes & Metabolism Research Institute at COH