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Evaluating the Benefits of Physiologic Insulin Delivery

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ClinicalTrials.gov Identifier: NCT04416737
Recruitment Status : Not yet recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Rayhan A. Lal, Stanford University

Brief Summary:
In normal physiology insulin is secreted by beta cells into the portal vein. There have been a number of purported benefits among long-term intraperitoneal insulin users. In the present study we will inject ultra-rapid acting insulin into the upper and lower peritoneum under ultrasound guidance and compare it to subcutaneous injection. We will measure glucose, insulin and glucagon following these injections, to assess for benefits in counter-regulatory hormone production and insulin pharmacokinetics.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: Ultra-rapid insulin Not Applicable

Detailed Description:
The eventual goal of this line of work is an implanted insulin pump that delivers insulin automatically into the peritoneum based on continuous glucose data. All prior intraperitoneal pharmacokinetic studies used only concentrated regular insulin, which may be too slow to provide full closed-loop insulin delivery without meal announcement. A description of intraperitoneal ultra-rapid insulin kinetics, as well as counter-regulatory hormonal factors that may counter hypoglycemia is needed. Upper versus lower peritoneal delivery may also affect insulin kinetics. A possible benefit of intraperitoneal insulin is restoration of glucagon response in longstanding diabetes and clearance of insulin by the liver, both of which could provide hypoglycemic rescue in automated insulin delivery systems.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will each come in for 3 visits separated by at least 1 week. During the first two visits they will be randomized to either upper or lower peritoneal injection followed by the other site. During the third visit a subcutaneous injection will be performed to provide comparative data to the standard of care.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluating the Benefits of Physiologic Insulin Delivery
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Upper Peritoneal, then Lower Peritoneal, then Subcutaneous
Ultra-fast acting insulin will be injected into the upper peritoneum then lower peritoneum then subcutaneous space.
Other: Ultra-rapid insulin
Following 3 hours of insulin suspension from insulin pump, participants will receive insulin injection in respective locations (separated by at least 1 week) and then have serial lab measurements (YSI glucose, insulin and glucagon) taken during induced hypoglycemia.

Experimental: Lower Peritoneal, then Upper Peritoneal, then Subcutaneous
Ultra-fast acting insulin will be injected into the lower peritoneum then upper peritoneum then subcutaneous space.
Other: Ultra-rapid insulin
Following 3 hours of insulin suspension from insulin pump, participants will receive insulin injection in respective locations (separated by at least 1 week) and then have serial lab measurements (YSI glucose, insulin and glucagon) taken during induced hypoglycemia.




Primary Outcome Measures :
  1. Glucagon response to induced hypoglycemia [ Time Frame: Peritoneal: Every 5 minutes for 100 minutes max; Subcutaneous: Every 15 minutes for 240 minutes max ]
    For each injection site we will assess the change in glucagon from nadir to peak during induced hypoglycemia.


Secondary Outcome Measures :
  1. Insulin concentration in plasma [ Time Frame: Peritoneal: Every 5 minutes for 100 minutes max; Subcutaneous: Every 15 minutes for 240 minutes max ]
  2. Glucose Values [ Time Frame: Peritoneal: Every 5 minutes for 100 minutes max; Subcutaneous: Every 15 minutes for 240 minutes max ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18-60 years of age
  2. Clinical diagnosis of type 1 diabetes
  3. On insulin pump therapy and continuous glucose monitor (CGM) for at least 3 months
  4. Ability to safely receive intraperitoneal injection
  5. For females, not currently known to be pregnant
  6. Understanding and willingness to follow the protocol and sign informed consent
  7. Ability to speak, read and write in the language of the investigators

Exclusion Criteria:

  1. Diabetic ketoacidosis in the past 3 months
  2. Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment
  3. Pregnant or lactating
  4. Active infection
  5. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
  6. Known cardiovascular events in the last 6 months
  7. Known seizure disorder
  8. Inpatient psychiatric treatment in the past 6 months
  9. Lack of stability on medication 1 month prior to enrollment including antihypertensive, thyroid, anti-depressant or lipid lowering medication.
  10. Suspected drug or alcohol abuse
  11. Chronic kidney disease (GFR < 60 mL/min/1.73m^2)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04416737


Contacts
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Contact: Rayhan Lal, MD 650-725-6549 inforay@stanford.edu
Contact: Bruce Buckingham, MD 650-804-0476 bbendo@stanford.edu

Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Rayhan Lal, MD Stanford University
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Responsible Party: Rayhan A. Lal, Med+Peds Endocrinologist, Stanford University
ClinicalTrials.gov Identifier: NCT04416737    
Other Study ID Numbers: IRB-57032
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs