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Time Restricted Eating + Standard of Care for Prediabetes (TIMET Trial)

N/A

Waitlist Available

Led By Pam Taub, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 14 weeks

Awards & highlights

TIMET Trial Summary

This trial will study the health impacts of eating within an 8-10 hour window for 12 weeks, in patients with metabolic syndrome who normally eat for more than 14 hours every day.

Eligible Conditions

Prediabetes
Metabolic Syndrome

TIMET Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 14 weeks 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 glucose levels assessed via HbA1c

Change in glycemic parameters

Secondary outcome measures

Change in HDL cholesterol

Change in LDL cholesterol

Change in LDL particle number

+3 more

Other outcome measures

Change in mitochondrial structure and gene expression in skeletal muscle

TIMET Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TRE + SOCExperimental Treatment1 Intervention

Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.

Group II: SOC (Standard of Care)Placebo Group1 Intervention

Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Time Restricted Eating + Standard of Care

2018

N/A

~160

Do I qualify?Apply below to find out

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Who is running the clinical trial?

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

2,357 Previous Clinical Trials

4,315,064 Total Patients Enrolled

Salk Institute for Biological StudiesOTHER

19 Previous Clinical Trials

1,685 Total Patients Enrolled

University of California, San DiegoLead Sponsor

1,120 Previous Clinical Trials

1,521,285 Total Patients Enrolled

Frequently Asked Questions

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

What is the expected outcome of this experiment?

"This clinical trial, which will evaluate progress over a span of 14 weeks from baseline, is intended to measure changes in fasting glucose. Other secondary outcomes that are being observed include variations in HbA1c (%), HDL cholesterol (mg/dl), and LDL particle number (nmol/L) as determined by NMR lipoprofile assessments."

Answered by AI

Does this trial include individuals over fifty years old in its enrollment criteria?

"For this particular study, only those falling within the age range of 18-75 qualify. Furthermore, 392 studies are available for younger people while 1191 trials exist specifically targeting older individuals."

Answered by AI

What are the criteria for individuals to be eligible for this experiment?

"Prospective candidates must fulfill two criteria: they need to have metabolic syndrome and be between 18-75 years of age. The clinical trial is aiming to enlist 122 participants in total."

Answered by AI

What is the capacity for this clinical experiment?

"Correct. Data hosted on clinicaltrials.gov attests that this experiment, which was first launched on April 8th 2019, is actively recruiting participants. Approximately 122 individuals must be enrolled from one medical site."

Answered by AI

Recent research and studies

Cell Reports MedicineJournal

Time for Better Time-restricted Eating Trials to Lessen the Burden of Metabolic Diseases

Taub, Pam R., and Satchidananda Panda. 2022. “Time for Better Time-restricted Eating Trials to Lessen the Burden of Metabolic Diseases”. Cell Reports Medicine. Elsevier BV. doi:10.1016/j.xcrm.2022.100665.

clinicaltrials.govStudy

The Influence of Time-Restricted Eating in Patients With Metabolic Syndrome

Pam Taub, MD 2019. "The Influence of Time-Restricted Eating in Patients With Metabolic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04057339.

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