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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
Must not have
Any chronic diseases including hypertension and Type 2 diabetes mellitus
Indication for lipid-lowering therapy in non-diabetics, using the more stringent AHA guideline cutoff (LDL>190 or an estimated 10-year ASCVD risk of >7.5%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a long-term illness like high blood pressure or Type 2 diabetes.
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I need medication to lower my cholesterol as per AHA guidelines.
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I am on long-term medications or birth control pills.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Trabecular bone microarchitecture
Triglyceride carbon content and degree of saturation
Secondary study objectives
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)

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,792 Previous Clinical Trials
16,359,896 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
~60 spots leftby Jun 2028
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