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Time Restricted Eating + Standard of Care for Metabolic Syndrome (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
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
- Metabolic Syndrome
- Prediabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 14 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 14 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in glucose levels assessed via HbA1c
Change in glycemic parameters
Secondary study objectives
Change in HDL cholesterol
Change in LDL cholesterol
Change in LDL particle number
+3 moreOther study objectives
Change in mitochondrial structure and gene expression in skeletal muscle
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
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,332,297 Total Patients Enrolled
35 Trials studying Metabolic Syndrome
2,818 Patients Enrolled for Metabolic Syndrome
Salk Institute for Biological StudiesOTHER
20 Previous Clinical Trials
1,833 Total Patients Enrolled
3 Trials studying Metabolic Syndrome
300 Patients Enrolled for Metabolic Syndrome
University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,925 Total Patients Enrolled
7 Trials studying Metabolic Syndrome
362 Patients Enrolled for Metabolic Syndrome
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