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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06354088
The ClinicalTrials.gov registry entry for NCT06354088 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 245-participant average among 120 other Insulin Resistance trials with a reported enrollment target (87% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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