Targeting Polyamines using DFMO in Persons with Type 1 Diabetes: A Randomized Double-Masked Placebo-Controlled Phase I/II Study to Evaluate the Safety Tolerability and Initial Pharmacodynamics of Multiple Ascending Doses
Primary Investigator
Cynthia K Teskey
Primary Investigator
E
Ellie Ryan
Primary Investigator
Enrolling By Invitation
12 years - 40 years
All
Phase
N/A
2 Locations
Brief description of study
The purpose of this study is to determine if different doses of a drug known as DFMO have an effect on reducing the amount of stress that is experienced by the body's beta cells and preserves residual c-peptide.
Detailed description of study
The purpose of this study is to determine if different doses of a drug known as DFMO have an effect on reducing the amount of stress that is experienced by the body's beta cells and preserves residual c-peptide.
Participants will be paid for their participation.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: type 1 diabetes,type i diabetes,diabetes,diabetic
-
Age: 12 years - 40 years
-
Gender: All
Inclusion Criteria
Clinical diagnosis of type 1 diabetes within 2-8 months
Normal hearing
Exclusion Criteria
Presence of severe, active disease that interferes with dietary intake or requires the use of chronic medication, with exception of well-controlled hypothyroidism and mild asthma not requiring oral steroids
Diabetes other than T1D
Chronic illness known to affect glucose metabolism
Inability to swallow pills
Psychiatric impairment or current use of anti-psychotic medication
Hematologic abnormalities
Impaired renal function
Pregnant
Clinical diagnosis of type 1 diabetes within 2-8 months
Normal hearing
Exclusion Criteria
Presence of severe, active disease that interferes with dietary intake or requires the use of chronic medication, with exception of well-controlled hypothyroidism and mild asthma not requiring oral steroids
Diabetes other than T1D
Chronic illness known to affect glucose metabolism
Inability to swallow pills
Psychiatric impairment or current use of anti-psychotic medication
Hematologic abnormalities
Impaired renal function
Pregnant
Updated on
04 Aug 2024.
Study ID: 1411735324
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