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Alpha-Adrenergic Blocker
Adrenergic Blockers for Type 1 Diabetes Post-Islet Transplant
Phase < 1
Waitlist Available
Led By Michael R Rickels, MD., MS
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
GROUP 1: Male and female subjects age 21 to 65 years
GROUP 1: Use of standard immunosuppression as specified
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during metabolic testing; this symptom questionnaire will be asked at the following time points: -15min, -1min, 30min, 60min,75min, 90min,120min, 150min, 165min, 180min.
Awards & highlights
Study Summary
This trial is looking at whether or not the sympathetic nervous system and hormones have an effect on islet cells in type 1 diabetics who have received intrahepatic islet transplants.
Who is the study for?
This trial is for adults aged 21-65 with type 1 diabetes who have had an islet cell transplant at least 6 months ago. They should be using standard immunosuppression, have stable graft function, and not require high doses of insulin. Women must not be pregnant or breastfeeding and willing to use contraception. Exclusions include severe chronic diseases, uncontrolled hypertension, obesity (BMI ≥30), abnormal organ functions, certain medication uses within the last month, and other conditions that could affect safety.Check my eligibility
What is being tested?
The study tests how blocking different parts of the nervous system affects blood sugar control in those who've received a pancreas cell transplant for diabetes. It involves three drugs: phentolamine (α-adrenergic blocker), propranolol (β-adrenergic blocker), and placebo. Participants will undergo glucose clamps under each condition in a randomized double-blind manner to see if these interventions influence their body's response to low blood sugar.See study design
What are the potential side effects?
Phentolamine may cause low blood pressure, nasal stuffiness or reflex tachycardia; Propranolol can lead to slow heart rate, low blood pressure, fatigue or shortness of breath; Placebo typically has no side effects but mimics treatment experience.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 65 years old.
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I am using standard immunosuppression medication as directed.
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My insulin needs are low and my blood sugar levels are under control.
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I have had type 1 diabetes since before I was 40, have been on insulin for over 10 years, and had islet transplantation more than 6 months ago.
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My insulin use is low and my blood sugar levels are controlled.
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I am using standard immunosuppressive drugs as directed.
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My insulin needs are low and my blood sugar levels are controlled.
Select...
I am between 21 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during metabolic testing; this symptom questionnaire will be asked at the following time points: -15min, -1min, 30min, 60min,75min, 90min,120min, 150min, 165min, 180min.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during metabolic testing; this symptom questionnaire will be asked at the following time points: -15min, -1min, 30min, 60min,75min, 90min,120min, 150min, 165min, 180min.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
C-PEPTIDE suppression during hyperinsulinemia euglycemia.
Glucagon
Secondary outcome measures
AUTONOMIC SYMPTOMS during hyperinsulinemia
EPINEPHRINE during hyperinsulinemia hypoglycemia.
Rates of ENDOGENOUS GLUCOSE PRODUCTION during hyperinsulinemia hypoglycemia.
Trial Design
5Treatment groups
Active Control
Placebo Group
Group I: Group 1-Phentolamine Intra-hepatic isletActive Control1 Intervention
The dose of phentolamine will be 0.95 μg/kg•min, which will provide a total dose of 0.20 mg/kg. It will be administered 1 x only via intravenous infusion over 3.5 hours, starting 30 min before conduct of a hyperinsulinemic euglycemic (90 min) followed by hypoglycemia (90 min) clamp.
Group II: Group 2 - Extra-hepatic isletActive Control1 Intervention
Hyperinsulinemic euglycemic (90 min) followed by hypoglycemia (90 min) clamp only.
Group III: Group 3 - Intra-hepatic auto isletActive Control1 Intervention
Hyperinsulinemic euglycemic (90 min) followed by hypoglycemia (90 min) clamp only.
Group IV: Group 1-Propranolol Intra-hepatic isletActive Control1 Intervention
The dose of propranolol will be 0.48 μg/kilogram•minute, which will provide a total dose of 0.10 mg/kg. It will be administered 1 x only via intravenous infusion over 3.5 hours, starting 30 min before conduct of a hyperinsulinemic euglycemic (90 min) followed by hypoglycemia (90 min) clamp.
Group V: Group 1- Placebo Intra-hepatic isletPlacebo Group1 Intervention
Placebo in 100mL NSS. Infuse Intravenously at 0.0095 ML/KG/MIN. 1 x only via intravenous infusion over 3.5 hours, starting 30 min before conduct of a hyperinsulinemic euglycemic (90 min) followed by hypoglycemia (90 min) clamp.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,077 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,528 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,230 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is below normal levels.I take more than 5 mg of prednisone daily or its equivalent.You have a body mass index (BMI) of 30 or higher.I am between 21 and 65 years old.I have a history of heart or blood vessel disease, or I am currently taking β-blocker medication.I have bronchial asthma.Your HbA1c level is 7.0% or higher.I haven't taken any diabetes medication except insulin in the last 4 weeks.I take more than 5 mg of prednisone daily or its equivalent.I am using standard immunosuppression medication as directed.I use 0.2 units/kg of insulin or more daily.My insulin needs are low and my blood sugar levels are under control.I have had type 1 diabetes since before I was 40, have been on insulin for over 10 years, and had islet transplantation more than 6 months ago.My liver tests are more than 1.5 times the normal limit.I have seizures not caused by very low blood sugar.I use at least 0.2 units per kg of insulin daily.I haven't taken any diabetes medication except insulin in the last 4 weeks.I use 0.2 units/kg of insulin or more daily.I have active heart or blood vessel disease.I have untreated hypothyroidism, Addison's disease, or Celiac disease.I am not pregnant, not breastfeeding, and willing to use contraception during the study.I haven't taken any diabetes medication except insulin in the last 4 weeks.I have had type 1 diabetes since before I was 40 and have been on insulin for over 10 years.I had my entire pancreas removed and received islet cell transplant over 6 months ago.My insulin use is low and my blood sugar levels are controlled.I have a seizure disorder not caused by very low blood sugar.I take more than 5 mg of prednisone daily or its equivalent.I am not pregnant, not breastfeeding, and willing to use contraception during the study.My hemoglobin is below the normal range for my gender.I have a seizure disorder not caused by very low blood sugar.I have untreated hypothyroidism, Addison's disease, or Celiac disease.I am using standard immunosuppressive drugs as directed.My insulin needs are low and my blood sugar levels are controlled.You have a body mass index (BMI) of 30 or more.I am between 21 and 65 years old.My liver tests are more than 1.5 times the normal limit.My kidney function is below normal levels.Your HbA1c level is 7.0% or higher.Your blood pressure is too high and not under control.Your HbA1c level is higher than 7.0%.I am not pregnant, not breastfeeding, and willing to use contraception during the study.My hemoglobin is below the normal range for my gender.You have a body mass index (BMI) of 30 or higher.I am between 21 and 65 years old.I have anemia with a hemoglobin level below the normal range for my gender.My liver tests are more than 1.5 times the normal limit.Your blood pressure is very high and not well controlled: higher than 160 over 100.Your blood pressure is very high and not well controlled, with a systolic value over 160 or a diastolic value over 100.My kidney function is below normal levels.I have active heart or blood vessel disease.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1-Phentolamine Intra-hepatic islet
- Group 2: Group 2 - Extra-hepatic islet
- Group 3: Group 3 - Intra-hepatic auto islet
- Group 4: Group 1-Propranolol Intra-hepatic islet
- Group 5: Group 1- Placebo Intra-hepatic islet
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research effort open to persons over the age of forty?
"This trial has specifically outlined that only individuals aged 21 to 65 can be enrolled. By contrast, there are 138 clinical studies for people younger than 18 and 262 trials targeting senior citizens over the age of 65 years old."
Answered by AI
What further investigations have been conducted concerning Group 1-Phentolamine Intra-hepatic islet?
"In total, there are 143 active clinical trials investigating Group 1-Phentolamine Intra-hepatic islet. Of those studies, 30 have already progressed to Phase 3. Most of these investigations are being conducted in Calgary, Alberta; however, the research has also spread out to 465 other medical centres around the world."
Answered by AI
Are there any opportunities for participants in this clinical research?
"According to the clinicaltrials.gov database, this experiment is no longer looking for participants; it was originally posted in January 2017 and last updated on March 3rd 2022. Even though this study has concluded its recruitment period, there are 447 other trials open to patient enrollment at present."
Answered by AI
How many participants can potentially be enrolled in this experiment?
"Sadly, this trial is no longer recruiting. The first post was made on the 20th of January 2017 and the last update occured on 3rd of March 2022. For patients searching for alternatives, there are presently 304 trials involving hypoglycemia and 143 studies concerning Group 1-Phentolamine Intra-hepatic that are actively enrolling participants."
Answered by AI
Is there an opportunity for me to join this experiment?
"Candidates must possess hypoglycemia and fall between the age range of 21 to 65 in order to be eligible for this study. A total of 11 participants are needed."
Answered by AI
What is the customary purpose associated with Group 1-Phentolamine Intra-hepatic islet?
"Group 1-Phentolamine Intra-hepatic islet can assist in managing increased intra ocular pressure (iop), but it also has medical applications such as treating nasal irritation, angina pectoris, and helping the kidneys excrete toxic substances."
Answered by AI
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