Could a gut hormone boost islet transplants and free type 1 diabetes patients from insulin shots?
NCT ID NCT03746769
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a natural gut hormone called gastrin to islet cell transplants can help people with hard-to-control type 1 diabetes produce their own insulin and stabilize blood sugar. About 20 adults aged 18-68 with unstable type 1 diabetes will receive donor islet cells plus gastrin. The goal is to see if they can stop insulin injections and avoid dangerous low blood sugar episodes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2019
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 68 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-68 years 2. 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. 3. Unstable blood glucose characterized by: Frequent hypoglycemia (blood glucose less than or equal to 54 mg/dl more than once per week) -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 4. 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. 5. Ability to give informed consent. 6. Fully vaccinated against COVID-19 Exclusion Criteria: 1. BMI \> 33 2. Insulin requirements \> 1.0 units/kg/day 3. Significant kidney disease (estimated GFR from serum creatinine measurement \<65 ml/min, random spot urine microalbumin to creatinine ratio \>300mg albumin/g creatinine) 4. 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) 5. Significant cardiovascular disease, including non-correctable coronary artery disease with ejection fraction \< 50% and/or recent myocardial infarction (within last 12 months); or extensive peripheral vascular disease not correctable by surgery, 6. Evidence of active proliferative retinopathy 7. Hypertension( \>/= 140/90) despite appropriate treatment 8. Hyperlipidemia (total cholesterol \> 260 mg/dl, LDL \> 160 mg/dl, and/or triglycerides \> 300 mg/dl) despite appropriate treatment 9. Anemia (Hgb \< 11 g/dl) or other hematologic disorders that require medical attention 10. WBC \<3,000/ul 11. Increased risk of bleeding (platelet count \< 120,000 cells/ul; INR \> 1.5), other chronic hemostasis disorders, or treatment with chronic anticoagulant therapy (i.e. heparin or warfarin) 12. Recent unresolved acute infection (except for mild skin infection or nail fungal infection), or chronic infection, including tuberculosis, HIV, HBV, HCV, CMV or syphilis (RPR) 13. EBV IgG negative 14. Any history of malignancy, except completely resected squamous or basal cell skin cancer or in situ cancer of the cervix 15. Evidence of active peptic ulcer disease 16. History of gastric bypass 17. Recent history of non-adherence to recommended medical therapy 18. Psychiatric illness that is untreated, or likely to interfere significantly with study compliance despite treatment 19. Previous organ/tissue transplant 20. Administration of live attenuated vaccines within 60 days of enrollment. 21. Presence of a chronic disease that must be chronically treated with contraindicated medications 22. Use of investigational agents within four weeks of enrollment 23. Active alcohol or substance abuse, including cigarette smoking (must be abstinent for \> 3 months) 24. Pregnant women, women intending future pregnancy, women of reproductive potential who are unable or unwilling to follow effective contraceptive measures (i.e., tubal ligation, two barrier methods, abstinence) for the duration of study treatment and for as long as they are on immunosuppressive medication, and women presently breastfeeding. 25. Individuals without health insurance covering the cost of immunosuppression and clinical and laboratory follow-up after completion of the study 26. Any medical condition that in the opinion of the investigator will interfere with safe participation in the trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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City of Hope Medical Center
RECRUITINGDuarte, California, 91010, United States
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