Type 1 Diabetes MellitusNCT02004964
Screening of Subjects With Type I Diabetes to Determine Eligibility for Islet Transplantation
An observational study of Type 1 Diabetes Mellitus, run by Rodolfo Alejandro at 1 site in United States.
Trial summary
Protocol to screen potential subjects for islet transplantation Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to 6 Nov 2018
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with type 1 DM
Who may be able to join
- Patients between 18 and 65 years of age
- Patients with type 1 diabetes mellitus for more than 5 years duration
- Body Mass Index (BMI)
- Fulfill one or more of the following:
- 1. Manifest signs and symptoms that are severe enough to be incapacitating. Incapacitating signs and symptoms include hypoglycemic episodes requiring assistance by others and hypoglycemia unawareness, (the inability to recognize low blood glucoses; glucoses <54 mg/dl); and/or 2. Patients with poor diabetes control (HbA1c > 8.0% but < 12%), despite intensive insulin therapy, as defined by: self monitoring of blood glucose ≥ 4 times/day, and multiple insulin injections (≥ 3/day) or insulin pump, and close monitoring of blood glucose control by an Endocrinologist.; and/or 3. Progressive diabetic complications.
- Exclusion Criteria: Potential candidates will be excluded as per following criteria:
Show all 46Show fewer
- Age <18 or >65 years;
- Duration of diabetes <5 years;
- Do not have a physician that is monitoring diabetes for > 6 months;
- Body Mass Index >30
- Weight >80 kg;
- Insulin requirement >1.0 u/kg/d;
- HbA1C >12%;
- Stimulated or basal C-peptide >0.3 ng/ml;
- Iohexol GFR<80
- Macroalbuminuria (>300 mg/24 hours);
- Anemia consistently lower than the normal range.
- Hyperlipidemia (fasting LDL cholesterol>130mg/dl and/or fasting triglycerides >200mg/dl);
- Abnormal liver function tests (consistently >1.5 x normal range);
- Serological evidence of HIV, HBsAg and/or HBcAb, HBsAb without history of vaccination, HTLV-1 or HCV;
- Negative serology for Epstein Barr virus (EBV) or evidence of acute or chronic infection (IgM≥IgG);
- Lack of updated immunizations per current CDC guidelines (including Lack of immunization against hepatitis B, pneumococcus and influenza - during season);
- Presence of panel reactive antibodies by flow cytometry
- Prostate specific antigen (PSA) >4 ng/ml unless malignancy ruled out;
- Positive tuberculin test (unless proof of adequate treatment can be provided);
- X-ray evidence of pulmonary infection or other significant pathology;
- Gall stones and/or portal hypertension and/or hemangioma on liver ultrasound;
- Abnormal abdominal or pelvic ultrasound (evidence of masses that are considered suspicious for malignancy or adenopathy);
- Active peptic ulcer disease;
- Active infections;
- Unstable cardiovascular status (including positive stress echocardiography if >age 35)/MI in the past 6 months/LVEF<30%)
- Untreated or unstable proliferative diabetic retinopathy;
- Previous/concurrent organ transplantation (except failed islet cell / pancreas transplantation);
- Malignancy or previous malignancy;
- Any medical condition requiring chronic use of steroids;
- Active alcohol or substance abuse; smoking in the last 6 months;
- Sexually active females who are not: a) post-menopausal, b) surgically sterile, or c) not using an acceptable method of contraception (oral contraceptives, Norplant, Depo-Provera, and barrier devices with spermicide are acceptable; condoms used alone are not acceptable);
- Positive pregnancy test or intent for future pregnancy, or male subject's intent to procreate;
- Any condition or any circumstances that makes it unsafe to undergo an islet cell transplant;
- Psychogenically unable to comply;
- Failed psychological evaluation.
- Persistent leukopenia (white blood cell count <3,000/uL on more than 3 occasions)
- Acute or chronic pancreatitis.
- Severe or unremitting diarrhea, vomiting or othe gastrointestinal disorder potentially interfering with the ability to absorb oral medications.
- Lymphopenia - < 1,000/uL 40 Neutropenia - <1,500/uL
- 41. Thrombocytopenia - <100,000/uL
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Protocol to screen potential subjects for islet transplantation
Read the detailed description
Subjects with Type 1 diabetes and history of severe hypoglycemia will undergo screening similar to the screening done for islet transplantation including: history; physical; chest X rays; upper GI series if history of ulcer; abdominal and pelvic ultrasound with careful attention to liver parenchyma and gallbladder; EKG; stress echocardiography if older than 35, psychological evaluation; autonomic and sensorimotor evaluation. They will also have a tuberculosis skin test (PPD), and pre-transplant laboratory tests, including: serology (for hepatitis B and C, HTLV I and II, Herpesvirus 1 and 2, CMV, EBV, Parvovirus B19, RPR and HIV); first morning urine (albumin, protein and creatinine), GFR; urinalysis and urine culture; CBC, chemistry, PT, PTT, INR, C-peptide (basal and stimulated), HbA1c, , lipid profile, LFTs, thyroid profile, blood typing, PRA, MHC determination, auto-antibodies (GAD65, IA2 and insulin), and if male, prostate specific antigen (PSA). Severity of glucose lability and hypoglycemia unawareness is assessed with Clarke score, Lability index, Mage and hypoglycemia score.
I
- Conditions
- Type 1 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
eligibility for islet transplantation
This trial has the objective to determine subject eligibility for future islet transplant trials using fasting labs (including CBC, Chemistry, PRA, auto-antibodies, coagulation panel and others); a mixed meal tolerance test, psychological evaluation and a physical exam.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startApr 2009
- Primary completion6 Nov 2018
- Study completion6 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rodolfo Alejandro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rodolfo Alejandro, University of Miami
- Investigators
- Rodolfo Alejandro, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004964
- Sponsor's protocol ID
- 20053135
- Status last verified
- Dec 2018
- First submitted
- 25 Nov 2013
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Subjects With Type I Diabetes to Determine Eligibility for Islet Transplantation
- ClinicalTrials.gov ID
- NCT02004964
- Acronym / sponsor ID
- 20053135
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rodolfo AlejandroUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- 6 Nov 2018 (actual)
- Study completion
- 6 Nov 2018 (actual)
- First posted
- 9 Dec 2013 (estimated)
- 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.
Protocol to screen potential subjects for islet transplantation
Detailed description
Subjects with Type 1 diabetes and history of severe hypoglycemia will undergo screening similar to the screening done for islet transplantation including: history; physical; chest X rays; upper GI series if history of ulcer; abdominal and pelvic ultrasound with careful attention to liver parenchyma and gallbladder; EKG; stress echocardiography if older than 35, psychological evaluation; autonomic and sensorimotor evaluation. They will also have a tuberculosis skin test (PPD), and pre-transplant laboratory tests, including: serology (for hepatitis B and C, HTLV I and II, Herpesvirus 1 and 2, CMV, EBV, Parvovirus B19, RPR and HIV); first morning urine (albumin, protein and creatinine), GFR; urinalysis and urine culture; CBC, chemistry, PT, PTT, INR, C-peptide (basal and stimulated), HbA1c, , lipid profile, LFTs, thyroid profile, blood typing, PRA, MHC determination, auto-antibodies (GAD65, IA2 and insulin), and if male, prostate specific antigen (PSA). Severity of glucose lability and hypoglycemia unawareness is assessed with Clarke score, Lability index, Mage and hypoglycemia score.
I
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with type 1 DM
Key inclusion criteria (46 listed)
- Patients between 18 and 65 years of age
- Patients with type 1 diabetes mellitus for more than 5 years duration
- Body Mass Index (BMI)
- Fulfill one or more of the following:
- 1. Manifest signs and symptoms that are severe enough to be incapacitating. Incapacitating signs and symptoms include hypoglycemic episodes requiring assistance by others and hypoglycemia unawareness, (the inability to recognize low blood glucoses; glucoses <54 mg/dl); and/or 2. Patients with poor diabetes control (HbA1c > 8.0% but < 12%), despite intensive insulin therapy, as defined by: self monitoring of blood glucose ≥ 4 times/day, and multiple insulin injections (≥ 3/day) or insulin pump, and close monitoring of blood glucose control by an Endocrinologist.; and/or 3. Progressive diabetic complications.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
eligibility for islet transplantation
Time frame: Baseline
This trial has the objective to determine subject eligibility for future islet transplant trials using fasting labs (including CBC, Chemistry, PRA, auto-antibodies, coagulation panel and others); a mixed meal tolerance test, psychological evaluation and a physical exam.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- 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.
Rodolfo Alejandro, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Rodolfo Alejandro at 1 site in United States.
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 46 inclusion and 0 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: finished, as of the sponsor's last update on 11 Dec 2018. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eligibility for islet transplantation (time frame: Baseline). 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 2018.