Time restricted feeding for Prediabetes

N/A
Recruiting
Led By Harsha Karanchi, MD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upvisit 1 and visit 2 approximately 12 weeks
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will test whether time restricted feeding, or eating within an 8-hour window, can improve health outcomes. There will be 2 groups, one that eats within an 8-hour window and one that doesn't, and various health outcomes will be measured. The study will last 3 1/2 months.

Eligible Conditions
  • Prediabetes
  • Breast Cancer
  • Time-Restricted Feeding

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 1 and visit 2 approximately 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1 and visit 2 approximately 12 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
Assess feasibility and adherence to time period of eating recommendations in both study groups.
Change in Advanced Glycation End Products (AGE) as assessed by plasma
Change in sRAGE(soluble receptor for AGE) levels
Secondary outcome measures
Adherence to time period of eating recommendation in both study groups: self reporting during virtual visits and through food photography / annotated entries.
Adherence to virtual visit with psychologist or dietician
Change in 24 hour urinary AGE levels
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Time restricted feedingExperimental Treatment1 Intervention
daily eating period of 8 hours, before 8 PM
Group II: ControlActive Control1 Intervention
daily eating period ≥ 12 hours
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time restricted feeding
2019
Completed Phase 2
~880

Find a site

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
900 Previous Clinical Trials
5,364,938 Total Patients Enrolled
Harsha Karanchi, MDPrincipal Investigator
Medical University of South Carolina

Media Library

Time restricted feeding Clinical Trial Eligibility Overview. Trial Name: NCT05038137 — N/A
Prediabetes Research Study Groups: Time restricted feeding, Control
Prediabetes Clinical Trial 2023: Time restricted feeding Highlights & Side Effects. Trial Name: NCT05038137 — N/A
Time restricted feeding 2023 Treatment Timeline for Medical Study. Trial Name: NCT05038137 — N/A

Frequently Asked Questions

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

What is the ambition of this clinical trial?

"The foremost purpose of this research, which is to be tracked for about 12 weeks over Visit 1 and Visit 2, will explore fluctuations in Advanced Glycation End Products (AGE) as observed through plasma. Secondary objectives consist of assessing the adherence rate with virtual visits to psychologists, measuring compliance with recommendations on eating times between study groups, and observing RAGE gene expression within peripheral blood mononuclear cells."

Answered by AI

How many individuals are currently taking part in this research initiative?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, which was first posted on May 4th 2022, is actively recruiting patients at the present time. Specifically, 44 individuals need to be enrolled from 1 specific site."

Answered by AI

Are there still opportunities for volunteers to join this clinical experiment?

"This clinical trial, first published on May 4th 2022, is actively enrolling patients as per information provided by clinicaltrials.gov and was last amended on September 19th 2022."

Answered by AI

Are minors within the age range of 25 and below eligible for participation in this research project?

"According to the stated criteria, enrolment into this clinical trial is limited to individuals between 40 and 60 years of age. The same website has 84 studies that are exclusively for minors and 2671 trials open solely for people over 65."

Answered by AI

Am I eligible to partake in this investigation?

"This trial is admitting 44 people with impaired glucose tolerance aged between 40 and 60. The prerequisites for enrolment are as follows: An age of at least 40 years old, but no more than 60; Postmenopausal women (no menstrual periods over the preceding 12 months) presenting with pre-diabetes (A1C 5.7-6.4% or fasting blood glucose 100-125 mg/dL); Lab results confirming A1c and/or fasting glucose must have been obtained within 12 months prior to signing consent form, ideally from a lab located on Medical University of South Carolina's campus which can be verified through their electronic"

Answered by AI
~11 spots leftby May 2024