WithdrawnPhase 1

Dexamethasone/Pancreatic Clamp P&F

Stopped: Investigators' scientific priorities shifted.

United States0Started 2024-07-01

Plain-language summary

This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the specific dose-response impact of insulin infusion rate (IIR) on blood glucose levels during a pancreatic clamp study in the setting of dexamethasone-induced insulin resistance. The investigators will recruit participants with a history of overweight/obesity but no history of prediabetes or diabetes. Participants will be rendered temporarily insulin resistant by taking seven doses of dexamethasone. They will then undergo two pancreatic clamp procedures in which individualized basal IIR are identified, followed in one by maintenance of basal IIR (maintenance hyperinsulinemia, MH) and in the other by a stepped decline in IIR (reduction toward euinsulinemia, RE). In both clamps the investigators will closely monitor plasma glucose and various metabolic parameters. The primary outcome will be the absolute and relative changes in steady-state plasma glucose levels at each stepped decline in IIR.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Men and women (using highly effective contraception if of childbearing potential) aged 18-65 years
. Body mass index of 25.0-39.9 kg/m2
. Able to understand written and spoken English and/or Spanish
. Evidence of normal glucose metabolism (euglycemia), represented by not meeting the American Diabetes Association's definitions for prediabetes, impaired fasting glucose (IFG), or diabetes on screening labs. Thus, participants must meet both of the following conditions on screening labs:
. Normal fasting serum insulin (fasting insulin level \< 12 μIU/mL) on screening labs
. Written informed consent (in English or Spanish) and any locally required authorization (e.g., Health Insurance Portability and Accountability Act) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Absolute values of plasma glucose

Timeframe: Up to 425 minutes from the start of the procedure

Relative change in plasma glucose

Timeframe: Up to 425 minutes from the start of the procedure

Absolute values of serum insulin

Timeframe: Up to 425 minutes from the start of the procedure

Relative change in serum insulin

Timeframe: Up to 425 minutes from the start of the procedure

Absolute values of serum C-peptide

Timeframe: Up to 425 minutes from the start of the procedure

Relative change in serum C-peptide

Timeframe: Up to 425 minutes from the start of the procedure

Trial details

NCT IDNCT06126354

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-30

View on ClinicalTrials.gov More Insulin Resistance trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Men and women (using highly effective contraception if of childbearing potential) aged 18-65 years
. Body mass index of 25.0-39.9 kg/m2
. Able to understand written and spoken English and/or Spanish
. Evidence of normal glucose metabolism (euglycemia), represented by not meeting the American Diabetes Association's definitions for prediabetes, impaired fasting glucose (IFG), or diabetes on screening labs. Thus, participants must meet both of the following conditions on screening labs:
. Normal fasting serum insulin (fasting insulin level \< 12 μIU/mL) on screening labs
. Written informed consent (in English or Spanish) and any locally required authorization (e.g., Health Insurance Portability and Accountability Act) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations.

What they're measuring

Absolute values of plasma glucose

Timeframe: Up to 425 minutes from the start of the procedure

Relative change in plasma glucose

Timeframe: Up to 425 minutes from the start of the procedure

Absolute values of serum insulin

Timeframe: Up to 425 minutes from the start of the procedure

Relative change in serum insulin

Timeframe: Up to 425 minutes from the start of the procedure

Absolute values of serum C-peptide

Timeframe: Up to 425 minutes from the start of the procedure

Relative change in serum C-peptide

Timeframe: Up to 425 minutes from the start of the procedure

Dexamethasone/Pancreatic Clamp P&F

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Dexamethasone/Pancreatic Clamp P&F

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria