A Phase 3 interventional study of 0.4mU Insulin followed by withdrawal period followed by 0.8mU study and 0.8mU Insulin followed by withdrawal period followed by 0.4mU study in Healthy, sponsored by Adrian Vella. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-21.
Sponsored by Adrian Vella · Phase 3, Interventional, and Basic science
The purpose of this research is to help understand the relative importance of changes in insulin secretion (which lowers glucose) and changes in glucagon (which raises glucose) to regulate metabolism and the body's ability to make glucose.
Study A (Insulin 0.4mU/Kg/min): Subjects will be admitted to the CRTU at approximately 1700 on the day prior to study. They will then consume a standard 10kcal/kg meal (55% carbohydrate, 30% fat, 15% protein, caffeine free) and fast overnight. Blood will then be sampled for baseline enrichment and 2H20 (1.67g/kg of body water) will be given in 3 divided doses at 2200, 2400 and 0200. The following morning (approximately 0530), a forearm vein will be cannulated to allow infusions to be performed. In addition, a cannula will be inserted retrogradely into a vein of the contra-lateral dorsum of the hand. This will be placed in a heated Plexiglas box maintained at around 120oF to allow sampling of arterialized venous blood. At approximately 0600 (-180 min), a primed, (10microCi prime, 0.1microCi/min continuous) infusion containing trace amounts of glucose labeled with [3-3H] glucose will be started and continued till 0900 (0 min).
At 0900 (0 min), the infusion will be varied so as to mimic the anticipated pattern of fall of EGP. In addition, glucose also labeled with [3-3H] glucose will be infused so as to maintain glucose concentrations at \~ 95mg/dL. Peripheral venous glucose concentrations will be measured every 10 minutes to allow the infusion rate of glucose to be adjusted as necessary.
Simultaneously, an infusion of somatostatin (60ng/kg/min) will be started at time 0 to inhibit endogenous islet secretion and therefore ensure identical portal insulin concentrations on the two study days. Insulin will be infused at a constant rate known to produce \~ 50% suppression of EGP (0.4mU/Kg/min).
From 0900 (0 min) to 1030 (90 min) no glucagon will be infused. Subsequently, a glucagon infusion will commence (91 - 180 min) at 0.35 ng/Kg/min and then increase to 0.70 ng/Kg/min (181- 270 min), a rate which will be maintained till the end of the study (1330).
Study B (0.8mU/Kg/min): Approximately 1-2 weeks after the first study visit, subjects will be asked to return to the CRTU. This study visit will be similar to Study A. However, insulin will be infused at 0.8mU/Kg/min 0 to 270 minutes.
Adrian Vella is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
During the euglycemic clamp insulin will be infused at 0.4mU/Kg/Min
Drug: 0.4mU Insulin followed by withdrawal period followed by 0.8mU study · Drug: 0.8mU Insulin followed by withdrawal period followed by 0.4mU study
During the euglycemic clamp insulin will be infused at 0.8mU/Kg/Min
Drug: 0.4mU Insulin followed by withdrawal period followed by 0.8mU study · Drug: 0.8mU Insulin followed by withdrawal period followed by 0.4mU study
Clamp study with insulin infused at 0.4 mU/Kg/min, followed by a 2 week withdrawal period followed by a clamp study with insulin infused at 0.8 mU/Kg/min
Also known as: 0.4 then 0.8
Clamp study with insulin infused at 0.8 mU/Kg/min, followed by a 2 week withdrawal period followed by a clamp study with insulin infused at 0.4 mU/Kg/min
Also known as: 0.8 then 0.4
Endogenous Glucose Production (EGP)
is calculated by tracer-based measurement and expressed per kg lean body mass
Time frame: It will be quantified at 90, 180 and 270 minutes for the study with 0.4mU insulin infusion and compared to values obtained for the study with 0.8mU insulin infusion at the same timepoints
| Milestone | 0.4 Then 0.8 | 0.8 Then 0.4 |
|---|---|---|
| Started | 5 | 7 |
| Completed | 5 | 5 |
| Not completed | 0 | 2 |
| Withdrew: Iv access lost during the study | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
is calculated by tracer-based measurement and expressed per kg lean body mass
| umol/kg/min | 0.4mU Insulin | 0.8mU Insulin |
|---|---|---|
| At 90 minutes | 4.99 ± 0.53 | 5.02 ± 0.74 |
| At 180 minutes | 6.82 ± 0.82 | 5.52 ± 0.96 |
| At 270 minutes | 8.48 ± 1.07 | 5.38 ± 1.13 |
Collected over 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 0.4 Events | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) |
| 0.8 Events | 0/12 (0%) | 0/12 (0%) | 2/12 (16.7%) |
| Event | 0.4 Events | 0.8 Events |
|---|---|---|
| PhlebitisBlood and lymphatic system disorders | 1/12 | 2/12 |
| NauseaGastrointestinal disorders | 1/12 | 0/12 |
| Age, Categorical(Participants) | 0.4 Then 0.8 | 0.8 Then 0.4 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 5 | 10 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | 0.4 Then 0.8 | 0.8 Then 0.4 | Total |
|---|---|---|---|
| Mean | 34 ± 13 | 37 ± 10 | 35 ± 11 |
| Sex: Female, Male(Participants) | 0.4 Then 0.8 | 0.8 Then 0.4 | Total |
|---|---|---|---|
| Female | 5 | 5 | 10 |
| Male | 0 | 2 | 2 |
| Race and Ethnicity Not Collected(Participants) | 0.4 Then 0.8 | 0.8 Then 0.4 | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | 0.4 Then 0.8 | 0.8 Then 0.4 | Total |
|---|---|---|---|
| United States | 5 | 7 | 12 |
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Adrian Vella