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Corticosteroid

Insulin Infusion for Blood Sugar Control in Obesity

Phase 1

Waitlist Available

Led By Joshua R Cook, MD, PhD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women (using highly effective contraception if of childbearing potential) aged 18-65 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

Study Summary

This trial will investigate how insulin infusion rate affects blood sugar levels in people with history of overweight/obesity but no diabetes.

Who is the study for?

This trial is for adults aged 18-65 with a BMI of 25.0-39.9, normal fasting insulin levels, and no history of diabetes or prediabetes. Participants must not be pregnant, breastfeeding, or have had recent weight-loss surgery and should not have any conditions that could interfere with the study.Check my eligibility

What is being tested?

The study tests how different rates of insulin infusion affect blood glucose in people made temporarily insulin resistant by dexamethasone. It involves two pancreatic clamp procedures to monitor glucose and metabolic changes under controlled conditions.See study design

What are the potential side effects?

Potential side effects may include reactions to dexamethasone such as increased blood sugar levels, mood changes, insomnia; discomfort from IV infusions; and possible allergic reactions to the substances used in the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old and use effective birth control if I can have children.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absolute values of plasma glucose

Absolute values of serum C-peptide

Absolute values of serum insulin

+3 more

Secondary outcome measures

Absolute values of serum or plasma apolipoprotein B (ApoB)

Absolute values of serum or plasma free fatty acid (FFA)

Absolute values of serum or plasma triglyceride (TG)

+6 more

Other outcome measures

Absolute values of serum or plasma growth hormone

Absolute values of serum/plasma glucagon

Relative change in serum or plasma glucagon

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Reduction toward euinsulinemia (RE) protocolExperimental Treatment12 Interventions

The basal insulin infusion rate (IIR) necessary to maintain participants' mean basal fasting plasma glucose (mbFPG) will be determined during the basal titration period. Then, during the intervention period, the IIR will be reduced progressively, at 75-min intervals, to 90%, 75%, and 60% of basal IIR. Thus, the basal hyperinsulinemia expected due to underlying insulin resistance will be reduced toward euinsulinemia.

Group II: Maintenance hyperinsulinemia (MH) protocolActive Control12 Interventions

The basal insulin infusion rate (IIR) necessary to maintain participants' mean basal fasting plasma glucose (mbFPG) will be determined during the basal titration period. Then, during the intervention period, the IIR will remain at 100% of basal for the full duration (225 min). The IIR and resulting insulin levels are expected to be relatively high (cf. hyperinsulinemia) because of dexamethasone-induced insulin resistance.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone Oral

2020

N/A

~14110

Octreotide Acetate

2016

Completed Phase 2

~260

Human Growth Hormone

2013

Completed Phase 2

~110

Insulin human

2014

Completed Phase 2

~20

Glucagon

2016

Completed Phase 4

~590

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Albert Einstein College of MedicineOTHER

287 Previous Clinical Trials

11,857,092 Total Patients Enrolled

6 Trials studying Insulin Resistance

194 Patients Enrolled for Insulin Resistance

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,460,999 Total Patients Enrolled

10 Trials studying Insulin Resistance

467 Patients Enrolled for Insulin Resistance

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,315,479 Total Patients Enrolled

87 Trials studying Insulin Resistance

13,209 Patients Enrolled for Insulin Resistance

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the key aims of this trial?

"This clinical trial evaluates the efficacy of a certain medical intervention over an interval of up to 7 hours. The primary outcome measured is absolute values of plasma glucose, while secondary outcomes being assessed include relative changes in serum/plasma free fatty acid and apolipoprotein B levels (both expressed as fold difference or delta mg/dL)."

Answered by AI

Are individuals aged fifty or more being accepted for this trial?

"Patients aged between 18 to 65 are eligible for this specific medical trial. There is an additional 114 clinical trials dedicated to minors and 782 others targeting seniors."

Answered by AI

Are there any vacancies for participants of this clinical trial?

"According to clinicaltrials.gov, this trial is not presently recruiting patients; it was published in December 1st 2023 and amended on November 6th 2023. Nevertheless, there are currently 1064 other trials that have open enrolment requirements for participants."

Answered by AI

Is admission open to join this medical experiment?

"Eligibility criteria for this trial necessitates that candidates have insulin resistance and are within the 18-65 year old age bracket. The study is looking to recruit nearly 16 patients."

Answered by AI