Screening of Subjects With Type I Diabetes to Determine Eligibility for Islet Transplantation

NCT02004964 | Completed

• 1 other identifier: 20053135
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Protocol to screen potential subjects for islet transplantation

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with type 1 DM

You may qualify if:

• 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:
• \. 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Rodolfo Alejandro: lead

Study Sites (1)

Diabetes Research Institute

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rodolfo Alejandro, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 9, 2013
• Study Start: April 1, 2009
• Primary Completion: November 6, 2018
• Study Completion: November 6, 2018
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

US (1)