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Effect of NNS on Metformin/GDF15, Pilot

NCT05400863 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-08-05

No results posted yet for this 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.

Conditions

  • Obesity, Adolescent
  • Pre Diabetes

Interventions

BEHAVIORAL

avoid sugary and NNS drinks plus start Metformin

Subjects will receive education and counseling to avoid all sweetened drinks (drink water only). Participants will be asked to consume minimum of 3 drinks/day

BEHAVIORAL

avoid sugary drinks (allowed water and drinks sweetened with NNS) plus start Metformin

Subjects will avoid drinks sweetened with sugar (can have diet drinks sweetened with NNS). Participants will be asked to consume minimum of 3 drinks/day

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Angelina Bernier, MD · University of Florida

  • Esraa Ismail, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-21
Primary Completion
2024-08-02
Completion
2024-08-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05400863 on ClinicalTrials.gov