Pancreatic Clamp in NAFLD
Completed · Phase 1
Conditions studied: Insulin Resistance, Prediabetic State, Hyperinsulinemia, Non-Alcoholic Fatty Liver Disease, Obesity
In brief
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. The investigators will recruit participants with a history of overweight/obesity and evidence of insulin resistance (i.e., fasting hyperinsulinemia plus prediabetes and/or impaired fasting glucose and/or Homeostasis Model Assessment of Insulin Resistance \[HOMA-IR\] score \>=2.73), and with evidence of, or clinically judged to be at high risk for, uncomplicated non-alcoholic fatty liver disease (NAFLD). Participants will 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.
Key facts
- Study ID
- NCT05724134
- Run by
- Columbia University
- People needed
- 18
- Starts
- 2023-08-29
- Expected to finish
- 2025-09-24
- Last updated by the study team
- 2026-01-12
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men and women (using highly effective contraception if of childbearing potential, aged 18-65 years
- Body mass index of 25-45 kg/m2
- Able to understand written and spoken English and/or Spanish
- Evidence of insulin resistance, represented by any or all of the following criteria:
- a. Meeting either of the American Diabetes Association's definitions for prediabetes or IFG within the previous year* and on screening labs: i. Prediabetes: Hemoglobin A1c 5.7-6.4% ii. IFG: plasma glucose of 100-125 mg dL-1 after 8-h fast b. Homeostasis Model of Insulin Resistance (HOMA-IR) score ≥ 2.73
- Fasting hyperinsulinemia (fasting insulin level ≥ 13 µIU/mL) on screening labs
- Diagnosed with, or clinically judged to be at high risk for, non-alcoholic fatty liver disease (NAFLD), also known as metabolic-associated fatty liver disease (MAFLD), by hepatologist or other qualified specialist physician and the condition is listed as an active problem in the electronic medical record
- 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.
You may not qualify if…
- Unable to provide informed consent in English or Spanish
- Concerns arising at screening visit (any of the following):
- i. Unwillingness to use only bedpan or urinal to void during the clamp
- ii. Unwillingness to fast (except water) for up to 22 hours
- iii. Documented weight loss of ≥ 5% of baseline within the previous 6 months
- iv. Abnormal blood pressure (including on treatment, if prescribed)
- Systolic blood pressure < 90 mm Hg or > 160 mm Hg, and/or
- Diastolic blood pressure < 60 mm Hg or > 100 mm Hg
- v. Abnormal resting heart rate: <60 or ≥100 bpm
- Sinus brady- or tachycardia that has been extensively worked up and considered benign by the recruit's personal physician may be permitted at the Principal Investigator's discretion
- vi. Abnormal screening electrocardiogram (or if on file, performed within previous 90 d)
- Non-sinus rhythm
- Significant corrected QT segment (QTc) prolongation (≥ 480 ms)
- New or previously unknown ischemic changes that persist on repeat EKG: 1. ST segment elevations; 2. T-wave inversions
- vii. Laboratory evidence of diabetes mellitus:
- Hemoglobin A1c ≥ 6.5%, and/or
- Fasting plasma glucose ≥ 126 mg/dL
- viii. Positive qualitative β-hCG (i.e., pregnancy test) in women of childbearing potential
- ix. Liver function abnormalities (either of the following) - Transaminases (AST or ALT) > 3.0 x the upper limit of normal - Total bilirubin > 1.25 x the upper limit of normal
- x. Abnormal fasting triglycerides at screening ≥ 400 mg/dL
- xi. Abnormal screening serum electrolytes (any of the following)
- Sodium, potassium, or bicarbonate outside of the reference range
- Creatinine equating to estimated glomerular filtration rate < 60 mL min-1 1.73 m-2
- xii. Abnormal complete blood count (CBC) (any of the following)
- Hemoglobin < 10 g dL-1 or hematocrit < 30%
Where it is running
- Columbia University Irving Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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