Primary outcome· 4 hours
AUC Postprandial Glucagon
| Group | Value |
|---|---|
| Pre-prandial Insulin Administration | not posted |
| Post-prandial Insulin Administration | not posted |
Trial · Interventional
TerminatedPhase 1/2Results postedRegistry dataGlucagon Response to Prandial Insulin Administration in Persons With Type 1 Diabetes
NCTNCT04079881 (opens ClinicalTrials.gov in a new tab)Other id201909013
This trial was stopped early.
Reason given at the registry: Loss of funding
Results were posted for this trial.
This trial does not test a peptide that PepBank tracks.
- Measures Glucagon, does not give it. It appears in an outcome measure.
Overview
- Status
- Terminated
- Phase
- Phase 1/2
- Enrollment
- 1 participants (actual)
- Sponsor
- Washington University School of Medicine · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 13 Feb 2020
- Primary completion
- 1 Jul 2020
- Completion
- 1 Jul 2020
- First posted
- 6 Sept 2019
- Last update posted
- 7 Oct 2022
- Conditions
- Type 1 Diabetes · Hyperglycemia, Postprandial
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20202021
- Ph 1/2Terminated
Glucagon Response to Prandial Insulin Administration in Persons With Type 1 Diabetes
NCT0407988113 Feb 2020 to 1 Jul 2020
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- InsulinDrug
Arms2
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.
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
AUC Postprandial Glucagon
Time frame · 4 hours
Registry description
Glucagon levels done fasting, 30, 60, 120, and 180 minutes
Secondary outcomes(1)
AUC Postprandial Glucose
Time frame · 4 hours
Registry description
* 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\*
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(1)
Secondary outcomeNumber· 4 hours
AUC Postprandial Glucose
| Group | Value (mg/dL) |
|---|---|
| Pre-prandial Insulin Administration | 245 |
| Post-prandial Insulin Administration: | 278 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Pre-prandial InsulinWill give short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min prior the meal. 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. | 0 / 1 | 0 / 1 | 0 / 1 |
| Post-prandial InsulinWill give short action insulin (Humalog, Lispro, etc.) with the same regiment patient was using at home 20 minutes after the meal. 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. | 0 / 1 | 0 / 1 | 0 / 1 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 90 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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