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Reduction toward euinsulinemia (RE) protocol for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Columbia University Irving Medical Center, New York, NYObesity+4 MoreGrowth Hormone, Human - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study how changing the rate of insulin infusion affects blood glucose levels in people with NAFLD.

Eligible Conditions
  • Obesity
  • Insulin Resistance
  • Prediabetes
  • Hyperinsulinemia
  • Non-alcoholic Fatty Liver Disease (NAFLD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

6 Primary · 9 Secondary · Reporting Duration: Measured every 5 minutes x 4 at the end of each steady-state IIR period, up to 425 minutes from the start of the procedure

Measured every 5 minutes x 4 at the end of each steady-state IIR period, up to 425 minutes from the start of the procedure
Plasma glucose kinetics: endogenous glucose production (units: mg/kg/min)
Plasma glucose kinetics: rate of appearance (units: mg/kg/min)
Plasma glucose kinetics: rate of disappearance (units: mg/kg/min)
Up to 425 minutes from the start of the procedure
Serum C-peptide (absolute values) (units: ng/mL)
Serum C-peptide (relative/change) (units: fold difference and/or ∆ µIU/mL relative to previous time points)
Serum or plasma apolipoprotein B (ApoB) (absolute values) (units: mg/dL)
Serum or plasma apolipoprotein B (ApoB) (relative/change) (units: fold difference and/or ∆mg/dL relative to previous time points)
Serum or plasma free fatty acid (FFA) (absolute values) (units: mg/dL)
Serum or plasma free fatty acid (FFA) (relative/change) (units: fold difference and/or ∆mg/dL relative to previous time points)
Serum or plasma glucagon (relative/change) (units: fold difference and/or ∆ng/L relative to previous time points)
Serum or plasma growth hormone (absolute values) (units: ng/mL)
Serum or plasma growth hormone (relative/change) (units: fold difference and/or ∆ng/mL relative to previous time points)
Serum or plasma triglyceride (TG) (absolute values) (units: mg/dL)
Serum or plasma triglyceride (TG) (relative/change) (units: fold difference and/or ∆mg/dL relative to previous time points)
Serum/plasma glucagon (absolute values) (units: ng/L)
Widely Targeted Lipidomic Profiling (WTLP)
Widely Targeted Small Polar Metabolite (WTSM) (metabolomics panel)
Up to 425 minutes from the start of the procedure.
Plasma glucose (absolute values) (units: mg/dL)
Plasma glucose (relative/change) (units: fold difference and/or ∆mg/dL relative to previous time points)
Serum insulin (absolute values) (units: micro-international units per milliliter (µIU/mL))
Serum insulin (relative/change) (units: fold difference and/or ∆ µIU/mL relative to previous time points)

Trial Safety

Safety Progress

1 of 3

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1
Diazoxide oral suspension, 1 mg per kg per dose
1
Alpelisib treatment
2
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Trial Design

2 Treatment Groups

Maintenance hyperinsulinemia (MH) protocol
1 of 2
Reduction toward euinsulinemia (RE) protocol
1 of 2

Active Control

Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: Reduction toward euinsulinemia (RE) protocol · No Placebo Group · Phase 1

Reduction toward euinsulinemia (RE) protocolExperimental Group · 9 Interventions: Growth Hormone, Human, [6,6-2H2] D-glucose, Octreotide Acetate, Insulin human, Glucagon, 20% D-glucose (aq), Harvard Apparatus PHD ULTRA CP syringe pump, BOOST Plus, Yellow Springs Instruments (YSI) 2500 Biochemistry Glucose/Lactate Analyzer · Intervention Types: Drug, Other, Drug, Drug, Drug, Drug, Device, DietarySupplement, Device
Maintenance hyperinsulinemia (MH) protocolActiveComparator Group · 9 Interventions: Growth Hormone, Human, [6,6-2H2] D-glucose, Octreotide Acetate, Insulin human, Glucagon, 20% D-glucose (aq), Harvard Apparatus PHD ULTRA CP syringe pump, BOOST Plus, Yellow Springs Instruments (YSI) 2500 Biochemistry Glucose/Lactate Analyzer · Intervention Types: Drug, Other, Drug, Drug, Drug, Drug, Device, DietarySupplement, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Octreotide Acetate
2016
Completed Phase 2
~260
Insulin human
2014
Completed Phase 2
~20
Glucagon
2016
Completed Phase 4
~590

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: measured every 5 minutes x 4 at the end of each steady-state iir period, up to 425 minutes from the start of the procedure

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,314 Previous Clinical Trials
1,623,978 Total Patients Enrolled
35 Trials studying Obesity
4,830 Patients Enrolled for Obesity
Albert Einstein College of MedicineOTHER
269 Previous Clinical Trials
1,839,644 Total Patients Enrolled
6 Trials studying Obesity
15,984 Patients Enrolled for Obesity
Joshua R. Cook, MD, PhDPrincipal InvestigatorColumbia University
Joshua R Cook, MD, PhDPrincipal InvestigatorColumbia University
2 Previous Clinical Trials
36 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between 18 and 65 years old and can be any gender.
You have a body mass index between 27.0 and 35.0, which means you may be overweight.
You have high blood sugar levels that are not yet in the diabetic range.
We may use a test to check your insulin resistance called HOMA-IR, but you must have at least one of the prediabetic conditions according to American Diabetes Association (ADA) guidelines.
Your insulin levels are too high after fasting for a certain period of time.
You have been diagnosed with, or are at high risk for, a liver disease called non-alcoholic fatty liver disease (NAFLD) or metabolic-associated fatty liver disease (MAFLD). This information is recorded in your electronic medical record.
You need to give your permission in writing (in English or Spanish) before any study procedures are done. You may also need to sign additional forms required by local laws.
You can read and understand English and/or Spanish.
References

Frequently Asked Questions

Is this research program open to adults who meet the age requirement?

"The age range set forth within the study's inclusion criteria is 18 to 65, with no exceptions." - Anonymous Online Contributor

Unverified Answer

Has the FDA sanctioned the Reduction toward euinsulinemia (RE) protocol?

"We anticipate that Reduction toward euinsulinemia (RE) protocol will possess a low safety score of 1 since this is only at the early stages of clinical trials. Little data exists to confirm either its efficacy or security." - Anonymous Online Contributor

Unverified Answer

Do I qualify to participate in this experiment?

"Eligible applicants to this study must be diagnosed with prediabetes and fall within the range of 18 to 65 years old. The clinical trial is looking for a total of 20 participants." - Anonymous Online Contributor

Unverified Answer

How many patients are currently being administered this clinical experiment?

"Confirmed. The research recorded on clinicaltrials.gov suggests that, starting from February 1st 2023, this medical trial is actively searching for patients to fill in the remaining twenty openings at a single site." - Anonymous Online Contributor

Unverified Answer

Is this experiment currently welcoming participants?

"Affirmative. Per the information on clinicaltrials.gov, this medical study is still open to recruitment and was initially posted in February 1st 2023; following a subsequent update on 2/2/2023, it now aims to enlist 20 individuals from one single location." - Anonymous Online Contributor

Unverified Answer

What objectives is this research endeavor seeking to accomplish?

"The primary measurement of this trial will occur over a period spanning up to 425 minutes, and is focused on serum insulin levels in µIU/mL. Secondary measurements include triglyceride concentrations in mg/dL, free fatty acid levels also in mg/dL, and the relative change between these values across time points." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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