NCT05400863Completed
Effect of NNS on Metformin/GDF15, Pilot
Can Sweetened Drinks Impair Therapeutic Effects of Metformin?
Source: ClinicalTrials.gov · Last updated 5 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 13 Apr 2022
- Start date
- 21 Apr 2022
- Primary completion date
- 2 Aug 2024
- Lead sponsor
- University of Florida
- Diseases
- Obesity
- NCT number
- NCT05400863
What you commit to
- Study type: Interventional
- Participants enrolled: 46
- From 21 Apr 2022 to the primary completion date, 2 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with oral hypoglycemic medications, (2) resting systolic blood pressure (SBP)\>180 mm/Hg or diastolic blood pressure (DBP)\>100mm/Hg, (3) self-reported pregnancy
Who the study is looking for
- Eligible patients will have already been prescribed Metformin as part of their normal clinical care
- Must also be aged 10-21 years
- 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%)
Age in the registry: 10 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UF pediatric metabolic and obesity clinic Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.