Effect of NNS on Metformin/GDF15, Pilot
Primary Purpose
Obesity, Adolescent, Pre Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
avoid sugary and NNS drinks plus start Metformin
avoid sugary drinks (allowed water and drinks sweetened with NNS) plus start Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Adolescent
Eligibility Criteria
Inclusion Criteria:
- 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%)
Exclusion Criteria:
- 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
Sites / Locations
- UF pediatric metabolic and obesity clinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Avoid Sugary Drinks and Artificially Sweetened Drinks ( plus Metformin)
Avoid sugary drinks only, allowed water and drinks with NNS (plus Metformin)
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT05400863
First Posted
April 13, 2022
Last Updated
September 20, 2023
Sponsor
University of Florida
1. Study Identification
Unique Protocol Identification Number
NCT05400863
Brief Title
Effect of NNS on Metformin/GDF15, Pilot
Official Title
Can Sweetened Drinks Impair Therapeutic Effects of Metformin?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Adolescent, Pre Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Avoid Sugary Drinks and Artificially Sweetened Drinks ( plus Metformin)
Arm Type
Experimental
Arm Description
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).
Arm Title
Avoid sugary drinks only, allowed water and drinks with NNS (plus Metformin)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
avoid sugary and NNS drinks plus start Metformin
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
avoid sugary drinks (allowed water and drinks sweetened with NNS) plus start Metformin
Intervention Description
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
Primary Outcome Measure Information:
Title
change in BMI z-score between the two groups at 12 weeks
Description
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)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
improvement of A1C due to metformin between the 2 groups at 12 weeks
Description
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)
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
metformin-induced rise in GDF15 in both groups at 12 weeks
Description
Compare post-intervention rise in GDF15 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)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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%)
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esraa Ismail, MD
Phone
352-294-5069
Email
esraaismail@ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Hosford
Phone
352-294-5759
Email
Jennifer.Hosford@medicine.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelina Bernier, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Esraa Ismail, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF pediatric metabolic and obesity clinic
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelina Bernier, MD
Phone
352-265-7337
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of NNS on Metformin/GDF15, Pilot
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