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Glucagon Response to Prandial Insulin Administration in Persons With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04079881
Recruitment Status : Active, not recruiting
First Posted : September 6, 2019
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Henry Jorge Zelada Castro, Washington University School of Medicine

Brief Summary:

Glucagon regulation and response in persons with T1D at the basal state and in response to various stimuli remains unclear. Dr. Philip Cryer has previously reported that, in T1D young adults with a course of the disease of 16+9 years, the absence of endogenous insulin secretion results in increased glucagon secretion after a mixed meal, concluding that endogenous insulin reciprocally regulates the alpha-cell glucagon secretion and also suggesting that glucagon dysregulation may play an important role in post-prandial hyperglycemia in T1D. Interestingly, recent research on human islets have shown that insulin inhibits counter-regulatory glucagon secretion by a paracrine effect mediated by SGLT2-dependent stimulation of somatostatin release. An important gap in our knowledge is whether the timing of prandial insulin doses affects the glucagon response to a hyperglycemic stimulus in patients with T1D who have undetectable C-peptide.

Whether appropriately timed exogenous insulin can modify the glucagon response to glucose fluctuations has not been studied. As such, this pilot study aims to characterize the glucagon response to meal-time hyperglycemia and to compare the difference in glucagon secretion when mealtime bolus insulin is given before the meal versus after the meal with the objective of understanding factors that contribute to the peak post-prandial blood glucose and AUC of blood glucose after a mixed meal in this target population.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Hyperglycemia, Postprandial Drug: Insulin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Glucagon Response to Prandial Insulin Administration in Persons With Type 1 Diabetes
Actual Study Start Date : February 13, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pre-prandial insulin
will give short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min prior the meal.
Drug: Insulin
to give pre-prandial and post-prandial insulin (will use patient insulin dose patient use at home) to patients with T1D and evaluate the response of post-prandial glucagon and post-prandial hyperglycemia.
Other Names:
  • Pre-prandial insulin
  • postprandial insulin

Experimental: Post-prandial insulin
will give short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min post the meal.
Drug: Insulin
to give pre-prandial and post-prandial insulin (will use patient insulin dose patient use at home) to patients with T1D and evaluate the response of post-prandial glucagon and post-prandial hyperglycemia.
Other Names:
  • Pre-prandial insulin
  • postprandial insulin




Primary Outcome Measures :
  1. AUC postprandial glucagon [ Time Frame: 4 hours ]
    • Glucose levels done fasting, 30, 60, 120, and 180 minutes
    • Glucagon levels done fasting, 30, 60, 120, and 180 minutes
    • Usual insulin dose will be administered 20 minutes prior to a mixed meal challenge with Ensure Plus*


Secondary Outcome Measures :
  1. AUC postprandial glucose [ Time Frame: 4 hours ]
    • Glucose done fasting, 30, 60, 120, and 180 minutes
    • Glucagon levels done fasting, 30, 60, 120, and 180 minutes
    • Usual insulin dose will be administered 20 minutes after the mixed meal challenge with Ensure Plus*



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 10 persons with T1D for >5 years age >18.
  • HbA1c <9.5%
  • Patients using either MDI or insulin pumps will be included.
  • Patients using CGM will continue the use during the study, however glucoses will be measured by laboratory methods.
  • Persons of all races, ethnicity and genders will be included
  • Participants should have normal hemoglobin, hematocrit and eGFR >60 ml/min/1.73m2.

Exclusion Criteria:

  • Persons with type 2 diabetes, monogenic diabetes, pancreatic diseases.
  • Pregnancy, prisoners, other vulnerable populations or persons unable to understand the protocol and provide written informed consent.
  • Persons who take daily steroids, any route, for any purpose

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): NCT04079881


Locations
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United States, Missouri
Washington University in St Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Janet McGill, MD Wash. Univ. School of Medicine
Publications:

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Responsible Party: Henry Jorge Zelada Castro, Endocrinology Fellow, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04079881    
Other Study ID Numbers: 201909013
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Henry Jorge Zelada Castro, Washington University School of Medicine:
glucagon
post-prandial glucose
type 1 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs