Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K23DK120932 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
The purpose of this study to compare the typically prescribed dose of metformin (1000mg twice a day) with a higher dose of metformin (1350mg twice a day).
Based on the investigators previous studies of young people who take metformin, the study team found that young people's bodies process metformin faster than older people and young people may need higher doses of metformin for the best treatment outcomes. The purpose of this study is to compare the typically prescribed dose of metformin (1000mg twice a day) with a higher dose of metformin (1350mg twice a day).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | 1350mg metformin twice per day |
|
| Active Comparator | Active Comparator | 1000mg metformin twice per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Participants will receive either 2700mg of metformin/day (1350mg twice a day) or 2000mg of metformin/day (1000mg twice a day, standard of care). The study intervention will be blinded to the participants as they will receive the same number of pills (4 pills of the same size) regardless of whether they are in the intervention arm or control arm . |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Higher Metformin Dose measured with the Acceptability of Intervention Measure (AIM) | The perception that a higher dose of Metformin is agreeable or satisfactory measured with the 4-item Acceptability of Intervention Measure (AIM). A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. The greater the score, the better the acceptability. | Measured at 3 months |
| Feasibility of Higher Metformin Dose measured with the Feasibility of Intervention Measure (FIM) | The extent to which a higher dose Metformin study can be successfully carried out measured with 4-item Feasibility of Intervention Measure (FIM). A 4-item instrument to assess perceived intervention feasibility. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. The greater the score, the better the feasibility. | Measured at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Change | Change in serum HbA1C at 3 months adjusted for the baseline value youth with T2D on higher dose of metformin compared to standard dose | Baseline (0) to 3 months |
| Time in target glucose range |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Avani A Narayan, MS | Contact | 628-224-8364 | avani.narayan@ucsf.edu | |
| Laura A. Dapkus Humphries, NCPT | Contact | 628-224-8364 | laura.dapkus@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shylaja Srinivasan, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic | Recruiting | Oakland | California | 94609 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Time spent in target glucose range of 70 to 180 mg/dL
| Baseline (0) to 3 months |
| Time above high glucose range | Percent of readings and time >250 mg/dL | Baseline (0) to 3 months |
| Time above glucose range | Percent of readings and time 181-250 mg/dL | Baseline (0) to 3 months |
| Time in glucose range | Percent of readings and time 70-180 mg/dL | Baseline (0) to 3 months |
| Time below glucose range | Percent of readings and time 54-69 mg/dL | Baseline (0) to 3 months |
| Time below low glucose range | Percent of readings and time <54 mg/dl | Baseline (0) to 3 months |
| Glucose management indicator | Continuous glucose monitoring (CGM) metric that indicates average blood glucose. Glucose Management Indicator (GMI) approximates the laboratory A1C level expected based on average glucose measured using CGM values. Average glucose is derived from 14 or more days of CGM readings. | Baseline (0) to 3 months |
| Co-efficient of variation of glucose | CGM metric that measures variability in CGM values | Baseline (0) to 3 months |
| UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric Diabetes | Recruiting | San Francisco | California | 94158 | United States |
|
| D004700 | Endocrine System Diseases |