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NCT06354088 · ClinicalTrials.gov registry record · Phase 1
Human Models of Selective Insulin Resistance: Alpelisib, Part I
A Phase 1 study of Insulin Resistance and Overweight and Obesity, sponsored by Columbia University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT06354088: Recruiting Phase 1 study of Insulin Resistance and Overweight and Obesity, sponsored by Columbia University.
NCT06354088 is a Phase 1 study of Insulin Resistance and Overweight and Obesity that is actively recruiting participants, run by Columbia University. The registered enrollment target is 32 participants, below the 245-participant average among 120 other Insulin Resistance trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06354088, a Phase 1 study of Insulin Resistance and Overweight and Obesity, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to understand how the blood sugar-lowering hormone insulin works in healthy adults versus those who are at risk for type 2 diabetes. The study will use a drug called alpelisib, which interferes with insulin's actions in the body, to answer the study's main question: does the liver continue to respond to insulin's stimulation of fat production even when it loses the ability to stop making glucose (sugar) in response to insulin. Researchers will compare the impact of single doses of both alpelisib and placebo (inert non-drug) in random order (like flipping a coin) in study participants. Participants will be asked to stay twice overnight in the hospital, take single doses of alpelisib and placebo (one or the other on each of the two hospital stays), and receive intravenous (into the vein) infusions of non-radioactive "tracer" molecules that allow researchers to measure the production of glucose (sugar) and fats by the liver. Measurements will be done both overnight, while participants are asleep and fasting (not eating or drinking other than water) and while consuming a standardized diet of nutritional beverages during the following day. The objective is to evaluate the effect of lowering insulin levels, while maintaining constant mild hyperglycemia, on plasma glucose and lipid levels.
Primary Outcome
Percent incorporation of newly synthesized fatty acids into plasma or VLDL TG. During both inpatient (overnight) study visits, starting after investigational agent dose. units: %
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Alpelisib 300 mg
- DRUG [1-13C] sodium acetate
- DRUG [6,6-2H2] D-glucose
- DIETARY_SUPPLEMENT Nestlé BOOST Plus
Study Locations (1)
New York
- Columbia University Irving Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2024-04-24 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT06354088 shows while recruiting
NCT06354088 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 245-participant average among 120 other Insulin Resistance trials with a reported enrollment target (87% lower).
The record links to 4 conditions, with Insulin Resistance appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT06354088 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06354088 about?
NCT06354088 is a clinical study titled "Human Models of Selective Insulin Resistance: Alpelisib, Part I". The goal of this clinical trial is to understand how the blood sugar-lowering hormone insulin works in healthy adults versus those who are at risk for type 2 diabetes. The study will use a drug called alpelisib, which interferes with insulin's actions in the body, to answer the study's main question...
What is the current status of trial NCT06354088?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2024-04-24. Estimated completion is 2026-12.
What conditions does trial NCT06354088 study?
This clinical trial studies the following conditions: Insulin Resistance, Overweight and Obesity, Non-alcoholic Fatty Liver Disease, Prediabetic State.
What interventions are being tested in trial NCT06354088?
The interventions under investigation include: Placebo (DRUG), Alpelisib 300 mg (DRUG), [1-13C] sodium acetate (DRUG), [6,6-2H2] D-glucose (DRUG), Nestlé BOOST Plus (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06354088?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06354088 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06354088's enrollment target sits among peer trials
32 84th of 120 higher than 35 of 120 other Insulin Resistance trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insulin Resistance trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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