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Overnight Metabolic Flexibility for Metabolism (METFLEX II Trial)

N/A

Waitlist Available

Research Sponsored by Pennington Biomedical Research Center

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4.5 hours

Awards & highlights

METFLEX II Trial Summary

This trial is testing a new way to measure how well the body can adapt to changes in food availability.

METFLEX II Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4.5 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4.5 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4.5 hours for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

change in respiratory exchange ratio during high-dose insulin infusion

peak decrease in overnight respiratory exchange ratio

Secondary outcome measures

Time to food quotient

Time to nadir respiratory exchange ratio

change in respiratory exchange ratio during low-dose insulin infusion

+2 more

METFLEX II Trial Design

1Treatment groups

Experimental Treatment

Group I: Sequential measurements of metabolic flexibilityExperimental Treatment2 Interventions

Study participants will undergo three assessments of metabolic flexibility. Two measurements of metabolic flexibility will be conducted during two separate overnight stay in a metabolic chamber approximately 5-7 days apart. The third measurement of metabolic flexibility will be assessed during a hyperinsulinemic-euglycemic clamp procedure conducted 7-28 days following the completion of the second overnight stay in the metabolic chamber.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Clamp Metabolic Flexibility

2021

N/A

~10

Overnight Metabolic Flexibility

2021

N/A

~10

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Who is running the clinical trial?

Pennington Biomedical Research CenterLead Sponsor

304 Previous Clinical Trials

181,426 Total Patients Enrolled

1 Trials studying Metabolism

54 Patients Enrolled for Metabolism

Frequently Asked Questions

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

Is enrollment for this experiment available at the present time?

"Clinicaltrials.gov states that this trial, which was first uploaded on August 26th 2021 and last updated on November 29th 2022 is not presently recruiting patients. Nevertheless, 14 additional clinical trials are currently engaging with participants."

Answered by AI

Is this clinical trial available to minors?

"The patient cohort for this specific medical study is comprised of individuals between 18 and 40 years old. There are 8 studies available to those over 65, while 1 trial exists specifically tailored towards minors."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Validating a Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber

David McDougal 2021. "Validating a Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05110274.