Obesity, AdolescentNCT05400863
Effect of NNS on Metformin/GDF15, Pilot
A study testing avoid sugary and NNS drinks plus start Metformin and avoid sugary drinks (allowed water and drinks sweetened with NNS) plus start Metformin in people with Obesity, Adolescent and Pre Diabetes, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Obesity, Adolescent, Pre Diabetes
- What is being tested?
- avoid sugary and NNS drinks plus start Metformin and avoid sugary drinks (allowed water and drinks sweetened with NNS) plus start Metformin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2022to 2 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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%)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UF pediatric metabolic and obesity clinic
Gainesville, Florida, 32608
About this study
Official title: Can Sweetened Drinks Impair Therapeutic Effects of Metformin?
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.
Read the detailed description
This study will enroll 40 children ages 10-21 years (will be recruited from the University of Florida (UF) Pediatric Obesity\& Metabolic clinic in Gainesville) and randomize eligible participants into a 2-arm, 12-week Metformin (500mg BID) intervention (n=20/group) in which one arm will be randomized to receive education and counseling to avoid all sweetened drinks (drink water only) and the other to avoid drinks sweetened with sugar (can have diet drinks sweetened with NNS). Participants will be asked to consume minimum of 3 drinks/day In the initial visit (baseline visit) the investigators will do a complete evaluations of physical health and eating behaviors. The investigators will draw lab work including A1c and GDF15 levels. The investigators will also get anthropometric measurements of height and weight to calculate body mass index (BMI). For assessment of beverage intake, the investigators reviewed questionnaires validated in children and adolescents in the past 10 years to better reflect currently available beverages. The investigators combined data from BEVQ-15 (that was validated in children aged 6-18 years) and BFQ(17 items questionnaire validated in young adults, aged 16-30 years),and edited further to make the important distinction between unsweetened and artificially sweetened drinks while adding several examples to each category to help improve correct selection. The investigators will also limit to weekly intake assessments. Data will be collected biweekly. Following completion of the 12-week intervention, participants will return fasting to assess the effectiveness of the metformin treatment on the following: hemoglobin A1C (A1c), Growth Differentiation Factor 15 (GDF15), with BMI and 24-hour dietary recall, including questions about change in hunger while on metformin. The investigators predict that metformin-induced GDF15 levels will be blunted in participants consuming NNS beverages. To improve compliance and decrease attrition, The investigators will provide performance feedback and interpretation of physiological parameters.
- Conditions
- Obesity, Adolescent, Pre Diabetes
- Being tested
- avoid sugary and NNS drinks plus start Metformin, avoid sugary drinks (allowed water and drinks sweetened with NNS) plus start Metformin
- Medical subject headings
- Pediatric Obesity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
avoid sugary and NNS drinks plus start MetforminBehavioural
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
avoid sugary drinks (allowed water and drinks sweetened with NNS) plus start MetforminBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Avoid Sugary Drinks and Artificially Sweetened Drinks ( plus Metformin) | Experimental | 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). Receives: Behavioral: avoid sugary and NNS drinks plus start Metformin |
| Avoid sugary drinks only, allowed water and drinks with NNS (plus Metformin) | Active comparator | 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). Receives: Behavioral: avoid sugary drinks (allowed water and drinks sweetened with NNS) plus start Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in BMI z-score between the two groups at 12 weeks
Compare post-intervention (metformin) body weight between participants randomized to receive education and counseling to either a) avoid all sweetened drinks (drink water only) or b) avoid drinks sweetened with sugar (can have diet drinks sweetened with NNS)
Measured: 12 weeks
Secondary outcomes (1)
improvement of A1C due to metformin between the 2 groups at 12 weeks
Compare post-intervention change in glycemic control between participants randomized to receive education and counseling to either a) avoid all sweetened drinks (drink water only) or b) avoid drinks sweetened with sugar (can have diet drinks sweetened with NNS)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start21 Apr 2022
- Primary completion2 Aug 2024
- Study completion2 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AdolescentStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angelina Bernier, MD, Principal investigator, University of FloridaEsraa Ismail, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400863
- Sponsor's protocol ID
- IRB202102435
- Status last verified
- Aug 2024
- First submitted
- 13 Apr 2022
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Sweetened Drinks Impair Therapeutic Effects of Metformin?
- ClinicalTrials.gov ID
- NCT05400863
- Acronym / sponsor ID
- IRB202102435
- Conditions
- Obesity, Adolescent, Pre Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will enroll 40 children ages 10-21 years (will be recruited from the University of Florida (UF) Pediatric Obesity\& Metabolic clinic in Gainesville) and randomize eligible participants into a 2-arm, 12-week Metformin (500mg BID) intervention (n=20/group) in which one arm will be randomized to receive education and counseling to avoid all sweetened drinks (drink water only) and the other to avoid drinks sweetened with sugar (can have diet drinks sweetened with NNS). Participants will be asked to consume minimum of 3 drinks/day In the initial visit (baseline visit) the investigators will do a complete evaluations of physical health and eating behaviors. The investigators will draw lab work including A1c and GDF15 levels. The investigators will also get anthropometric measurements of height and weight to calculate body mass index (BMI). For assessment of beverage intake, the investigators reviewed questionnaires validated in children and adolescents in the past 10 years to better reflect currently available beverages. The investigators combined data from BEVQ-15 (that was validated in children aged 6-18 years) and BFQ(17 items questionnaire validated in young adults, aged 16-30 years),and edited further to make the important distinction between unsweetened and artificially sweetened drinks while adding several examples to each category to help improve correct selection. The investigators will also limit to weekly intake assessments. Data will be collected biweekly. Following completion of the 12-week intervention, participants will return fasting to assess the effectiveness of the metformin treatment on the following: hemoglobin A1C (A1c), Growth Differentiation Factor 15 (GDF15), with BMI and 24-hour dietary recall, including questions about change in hunger while on metformin. The investigators predict that metformin-induced GDF15 levels will be blunted in participants consuming NNS beverages. To improve compliance and decrease attrition, The investigators will provide performance feedback and interpretation of physiological parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avoid Sugary Drinks and Artificially Sweetened Drinks ( plus Metformin) | Experimental | Behavioral: avoid sugary and NNS drinks plus start MetforminCounseling 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). |
| Avoid sugary drinks only, allowed water and drinks with NNS (plus Metformin) | Active comparator | Behavioral: avoid sugary drinks (allowed water and drinks sweetened with NNS) plus start MetforminCounseling 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). |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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%)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| avoid sugary and NNS drinks plus start MetforminSubjects will receive education and counseling to avoid all sweetened drinks (drink water only). Participants will be asked to consume minimum of 3 drinks/day | Behavioural | Avoid Sugary Drinks and Artificially Sweetened Drinks ( plus Metformin) |
| avoid sugary drinks (allowed water and drinks sweetened with NNS) plus start MetforminSubjects will avoid drinks sweetened with sugar (can have diet drinks sweetened with NNS). Participants will be asked to consume minimum of 3 drinks/day | Behavioural | Avoid sugary drinks only, allowed water and drinks with NNS (plus Metformin) |
Primary outcome
change in BMI z-score between the two groups at 12 weeks
Time frame: 12 weeks
Compare post-intervention (metformin) body weight between participants randomized to receive education and counseling to either a) avoid all sweetened drinks (drink water only) or b) avoid drinks sweetened with sugar (can have diet drinks sweetened with NNS)
1 secondary outcome
improvement of A1C due to metformin between the 2 groups at 12 weeks
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelina Bernier, MD principal investigator
University of Florida
Esraa Ismail, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing avoid sugary and NNS drinks plus start Metformin and avoid sugary drinks (allowed water and drinks sweetened with NNS) plus start Metformin in people with Obesity, Adolescent and Pre Diabetes, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in BMI z-score between the two groups at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.