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Non-Nutritive Sweeteners + Metformin for Prediabetes

N/A
Recruiting
Led By Angelina Bernier, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a diagnosis of obesity (BMI > 95th%ile or >30 kg/m2 - whichever is lower) and pre-diabetes (A1c between 5.7 and 6.4%)
Must also be aged 10-21 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will test if non-nutritive sweetened drinks impair the benefits of metformin for diabetes, including weight loss and glucose tolerance.

Who is the study for?
This trial is for young individuals aged 10-21 with obesity and pre-diabetes who are already taking Metformin. They must have a BMI over the 95th percentile or greater than 30 kg/m2, and an A1c level between 5.7% and 6.4%. Those with very high blood pressure or previous diabetes medication use, as well as pregnant individuals, cannot participate.Check my eligibility
What is being tested?
The study tests if avoiding sugary drinks (with or without non-nutritive sweeteners) affects weight loss and glucose control in participants on Metformin. It aims to see whether drinks sweetened with NNS impact the drug's ability to reduce appetite, body weight, and improve blood sugar levels in children.See study design
What are the potential side effects?
While not specified here, common side effects of Metformin include digestive issues like nausea or diarrhea; it may also cause a metallic taste in the mouth. The effect of NNS on these side effects will be observed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am diagnosed with obesity and pre-diabetes.
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I am between 10 and 21 years old.
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I am currently taking Metformin as prescribed by my doctor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
change in BMI z-score between the two groups at 12 weeks
Secondary outcome measures
improvement of A1C due to metformin between the 2 groups at 12 weeks
Other outcome measures
metformin-induced rise in GDF15 in both groups at 12 weeks

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Avoid Sugary Drinks and Artificially Sweetened Drinks ( plus Metformin)Experimental Treatment1 Intervention
Counseling on Beverage Intake to avoid sugary sweetened and NNS (non-nutritive sweetened) drinks plus Metformin therapy (subjects will be given 12-week Metformin (500mg BID) as standard of care therapy).
Group II: Avoid sugary drinks only, allowed water and drinks with NNS (plus Metformin)Active Control1 Intervention
Counseling on Beverage Intake to avoid sugary drinks (allowed water and drinks sweetened with NNS) plus Metformin therapy (subjects will be given 12-week Metformin (500mg BID) as standard of care therapy).

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,338 Previous Clinical Trials
715,276 Total Patients Enrolled
Angelina Bernier, MDPrincipal InvestigatorUniversity of Florida
Esraa Ismail, MDPrincipal InvestigatorUniversity of Florida

Media Library

Avoidance of sugary and NNS drinks plus start Metformin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05400863 — N/A
Prediabetes Research Study Groups: Avoid Sugary Drinks and Artificially Sweetened Drinks ( plus Metformin), Avoid sugary drinks only, allowed water and drinks with NNS (plus Metformin)
Prediabetes Clinical Trial 2023: Avoidance of sugary and NNS drinks plus start Metformin Highlights & Side Effects. Trial Name: NCT05400863 — N/A
Avoidance of sugary and NNS drinks plus start Metformin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05400863 — N/A

Frequently Asked Questions

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

How many participants is the trial currently enrolling?

"Affirmative, the information hosted on clinicaltrials.gov affirms that this medical experiment is actively searching for participants. It was initially publicized April 21st 2022 and most recently updated August 31st 2022. 40 people are needed to be recruited from a single site."

Answered by AI

Could I qualify to partake in this research?

"This clinical trial seeks 40 participants aged 10-21 with impaired glucose tolerance. Candidates must have a Body Mass Index (BMI) exceeding the 95th percentile or 30 kg/m2, and an A1c between 5.7 to 6.4%. Additionally, they should already be taking Metformin as part of their regular treatment plan."

Answered by AI

Is it currently feasible to sign up for this research endeavor?

"Clinicaltrials.gov has recorded that this research project, initially listed on April 21st 2022 and recently updated on August 31st 2022, is actively searching for participants."

Answered by AI

Are participants in this study of any particular age or older?

"This research team is recruiting participants that are between 10 and 21 years old."

Answered by AI
~2 spots leftby May 2024