Table 1.
Study Measures (months)
| Item | 0 | 12 | 24 | 36 |
|---|---|---|---|---|
| Blood1 | ||||
| Fasting glucose and insulin | x | x | x | x |
| HbA1c | x | x | x | x |
| Fasting lipid panel | x | x | x | x |
| Liver and kidney panels | x | x | x | x |
| Vitamin B12 | x | x | ||
| Plasma Metformin2 | x | x | ||
| Urine1 | ||||
| Microalbuminuria | x | x | x | x |
| Anthropometric and clinic measures | ||||
| Blood pressure | x | x | x | x |
| Weight, height, and BMI | x | x | x | x |
| Waist and hip circumferences | x | x | x | x |
| Interviews/Questionnaires | ||||
| Adherence to metformin Rx3 | x | x | x | x |
| Food frequency | x | x | x | x |
| Food insecurity | x | x | x | x |
| Physical activity | x | x | x | x |
| Contact and sociodemographics | ||||
| Tobacco and alcohol use | x | x | x | x |
| History of hypertension, obesity, hyperlipidemia, heart disease (self-report and chart review) | x | x | x | x |
| Family history of diabetes in 1st degree relatives | x | x | x | x |
| Current medication use (self-report and chart review) | x | x | x | x |
| Lifestyle changes self-efficacy | x | x | x | x |
| Quality of life | x | x | x | x |
1
Biomarkers are analyzed centrally at the Salvador Zubiran National Institute of Medical Sciences and Nutrition
2
ln LS+M arm, all 12- and −24-month samples will be included; a 10% random sample from LSO arm will also be included.
3
Applies to patients on LS+M arm only; in addition, adherence is measured monthly.