avoid sugary and NNS drinks plus start Metformin for Impaired Glucose Tolerance

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UF pediatric metabolic and obesity clinic, Gainesville, FL
Impaired Glucose Tolerance+3 More
avoid sugary and NNS drinks plus start Metformin - Behavioral
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

Metformin use for diabetes has the benefit of causing weight loss in some. The investigators in a preclinical trial, demonstrated that mice consuming non-nutritive sweetened (NNS) drinks had worse glucose improvements and weight loss than mice consuming sugar drinks or water. This study will conduct a pilot to determine if this translates into pediatric clinical practice. The hypothesis is that NNS drinks impair metformin-induced satiation, weight loss, and glucose tolerance.

Eligible Conditions

  • Impaired Glucose Tolerance
  • Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Impaired Glucose Tolerance

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 12 weeks

12 weeks
change in BMI z-score between the two groups at 12 weeks
improvement of A1C due to metformin between the 2 groups at 12 weeks
metformin-induced rise in GDF15 in both groups at 12 weeks

Trial Safety

Safety Progress

1 of 3

Other trials for Impaired Glucose Tolerance

Trial Design

2 Treatment Groups

Avoid sugary drinks only, allowed water and drinks with NNS (plus Metformin)
1 of 2
Avoid Sugary Drinks and Artificially Sweetened Drinks ( plus Metformin)
1 of 2
Active Control
Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: avoid sugary and NNS drinks plus start Metformin · No Placebo Group · N/A

Avoid Sugary Drinks and Artificially Sweetened Drinks ( plus Metformin)
Behavioral
Experimental Group · 1 Intervention: avoid sugary and NNS drinks plus start Metformin · Intervention Types: Behavioral
Avoid sugary drinks only, allowed water and drinks with NNS (plus Metformin)
Behavioral
ActiveComparator Group · 1 Intervention: avoid sugary drinks (allowed water and drinks sweetened with NNS) plus start Metformin · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
Closest Location: UF pediatric metabolic and obesity clinic · Gainesville, FL
Photo of Gainesville 1Photo of Gainesville 2Photo of florida 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Impaired Glucose Tolerance
0 CompletedClinical Trials

Who is running the clinical trial?

University of FloridaLead Sponsor
1,228 Previous Clinical Trials
696,403 Total Patients Enrolled
1 Trials studying Impaired Glucose Tolerance
39 Patients Enrolled for Impaired Glucose Tolerance
Esraa Ismail, MDPrincipal InvestigatorUniversity of Florida
Angelina Bernier, MDPrincipal InvestigatorUniversity of Florida

Eligibility Criteria

Age < 65 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are aged 10-21 years.
You are eligible if you have already been prescribed Metformin as part of your normal clinical care.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.