Glucagon Response to Prandial Insulin Administration in Persons With Type 1 Diabetes
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ClinicalTrials.gov Identifier: NCT04079881 |
Recruitment Status :
Terminated
(Loss of funding)
First Posted : September 6, 2019
Results First Posted : March 2, 2022
Last Update Posted : October 7, 2022
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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 |
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Type 1 Diabetes Hyperglycemia, Postprandial | Drug: Insulin | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Participants are randomly assigned receive intervention A then intervention B or to receive intervention B than intervention A |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Glucagon Response to Prandial Insulin Administration in Persons With Type 1 Diabetes |
Actual Study Start Date : | February 13, 2020 |
Actual Primary Completion Date : | July 1, 2020 |
Actual Study Completion Date : | July 1, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: A (Pre-prandial insulin administration) : B (post-prandial insulin administration)
VISIT 1: 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. Then VISIT 2: 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:
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Experimental: B (post-prandial insulin administration) : A (Pre-prandial insulin administration) :b
VISIT 1: 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. Then VISIT 2: 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:
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- AUC Postprandial Glucagon [ Time Frame: 4 hours ]Glucagon levels done fasting, 30, 60, 120, and 180 minutes
- 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 before or 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 |
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
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
United States, Missouri | |
Washington University in St Louis | |
Saint Louis, Missouri, United States, 63110 |
Principal Investigator: | Janet McGill, MD | Wash. Univ. School of Medicine |
Documents provided by Washington University School of Medicine:
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT04079881 |
Other Study ID Numbers: |
201909013 |
First Posted: | September 6, 2019 Key Record Dates |
Results First Posted: | March 2, 2022 |
Last Update Posted: | October 7, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
glucagon post-prandial glucose type 1 diabetes |
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 |