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Intermittent Fasting for Prediabetes and Obesity

N/A

Recruiting

Led By Pouneh Fazeli, MD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

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

Must have

Men and women, ages 25-45 years

Normal thyroid function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months

Awards & highlights

Study Summary

This trial will explore the metabolic effects of fasting, and if those effects, including on bone metabolism, are independent of weight loss.

Who is the study for?

This trial is for men and women aged 25-45 with a BMI between 21-29, normal thyroid function, regular menstrual cycles for women, and a family history of type 2 diabetes. It's not suitable for those on chronic medications, pregnant or breastfeeding individuals, people with certain vitamin deficiencies or high cholesterol risks, those with eating disorders or substance abuse issues.Check my eligibility

What is being tested?

The study examines the metabolic effects of intermittent fasting without daily dietary restrictions to see if benefits like weight loss are independent of fasting itself. Participants will undergo fasting protocols alongside counseling sessions aimed at maintaining their current weight.See study design

What are the potential side effects?

While specific side effects aren't listed in the provided information, potential concerns may include negative impacts on bone metabolism due to caloric restriction associated with intermittent fasting.

Eligibility Criteria

Inclusion Criteria

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

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I am between 25 and 45 years old.

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My thyroid function is normal.

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I have regular menstrual cycles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months

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

Treatment Details

Study Objectives

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

Primary outcome measures

Trabecular bone microarchitecture

Triglyceride carbon content and degree of saturation

Secondary outcome measures

Insulin sensitivity

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Fasting with weight maintenanceExperimental Treatment2 Interventions

Subjects will fast one-day per week for 12 weeks and maintain body weight

Group II: FastingExperimental Treatment1 Intervention

Subjects will fast one-day per week for 12 weeks

Group III: CounselingPlacebo Group1 Intervention

Subjects will be counseled on optimal diet and activity recommendations to maintain/achieve a normal BMI (standard of care)

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,725 Previous Clinical Trials

16,305,711 Total Patients Enrolled

Pouneh Fazeli, MDPrincipal InvestigatorUniversity of Pittsburgh

1 Previous Clinical Trials

66 Total Patients Enrolled

Media Library

Fasting (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05722873 — N/A

Prediabetes Research Study Groups: Fasting with weight maintenance, Counseling, Fasting

Prediabetes Clinical Trial 2023: Fasting Highlights & Side Effects. Trial Name: NCT05722873 — N/A

Fasting (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05722873 — N/A

Frequently Asked Questions

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

Is this research study open to individuals above the age of 45?

"Patients aged 25 to 45 are eligible for this trial, as specified by its inclusion criteria. The database of clinical trials also houses 52 experiments geared towards minors and 200 aimed at patients 65 years and older."

Answered by AI

Are there any open opportunities to participate in this clinical trial?

"As per records from clinicaltrials.gov, the recruitment phase for this medical trial has ceased; it was initially posted on July 1st 2023 and last altered February 1st 2023. Nevertheless, there are 324 other studies that are actively accepting participants at present."

Answered by AI

Is it possible for me to enroll in this clinical research?

"This medicinal research is admitting 90 individuals aged 25 to 45, who are either of normal weight or overweight and have a heightened chance of getting diabetes. Additional prerequisites include being male/female, having a body mass index between 21-29 kg/m2, regular menstrual cycles (if applicable), healthy thyroid function, and at least one first-degree relative with type 2 diabetes (T2D) or past gestational diabetes history."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Metabolic Effects of Intermittent Fasting

Pouneh K. Fazeli, MD 2023. "The Metabolic Effects of Intermittent Fasting". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05722873.