Pancreatic Clamp in NAFLD (NCT05724134) | Clinical Trial Compass
CompletedPhase 1
Pancreatic Clamp in NAFLD
United States18 participantsStarted 2023-08-29
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. 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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.
Exclusion criteria
✕
What they're measuring
1
Plasma glucose (absolute values) (units: mg/dL)
Timeframe: Up to 425 minutes from the start of the procedure.
2
Plasma glucose (relative/change) (units: fold difference and/or ∆mg/dL relative to previous time points)
Timeframe: Up to 425 minutes from the start of the procedure.
3
Serum insulin (absolute values) (units: micro-international units per milliliter (µIU/mL))
Timeframe: Up to 425 minutes from the start of the procedure.
4
Serum insulin (relative/change) (units: fold difference and/or ∆ µIU/mL relative to previous time points)
Timeframe: Up to 425 minutes from the start of the procedure.
5
Serum C-peptide (absolute values) (units: ng/mL)
Timeframe: Up to 425 minutes from the start of the procedure
6
Serum C-peptide (relative/change) (units: fold difference and/or ∆ µIU/mL relative to previous time points)
Timeframe: Up to 425 minutes from the start of the procedure
. Unable to provide informed consent in English or Spanish
✕. Concerns arising at screening visit (any of the following):
✕. Unwillingness to comply with masking and COVID-19 testing requirements per NYP/CUMC policy
✕. Reproductive concerns i. Women of childbearing potential not using highly effective contraception, defined as:
✕. Concerns related to glucose metabolism i. History of having met any of the American Diabetes Association's definitions of diabetes mellitus (i.e., overt diabetes) ii. History of gestational diabetes mellitus within the previous 5 years iii. Use of antidiabetic medications other than metformin within the 90 days prior to screening, including those prescribed for other indications (e.g., weight control, restoration of ovulation in of polycystic ovarian syndrome) iv. Clinical concern for absolute insulin deficiency (e.g., type 1 diabetes, pancreatic disease) v. Fasting plasma glucose \< 89 mg/dL at screening
✕. Concerns related to lipid metabolism i. Known diagnoses of familial hypercholesterolemia, familial combined hyperlipidemia, or familial hyperchylomicronemia in the participant or a first-degree relative ii. Use of certain lipid-lowering drugs other than statins for primary prevention within 90 d prior to screening visit, including: • Statins or PCSK9 inhibitors for secondary prevention or treatment of familial hypercholesterolemia. Statins or PCSK9 inhibitors for primary prevention of ASCVD are acceptable.
✕. Known, documented history, at the time of screening, of any of the following medical conditions:
✕. Clinical concern for increased risk of volume overload, including due to medications and/or heart/liver/kidney problems, as listed above