Vigabatrin and Insulin Sensitivity
關鍵詞
抽象
日期
| 最後驗證: | 02/29/2020 |
| 首次提交: | 03/22/2020 |
| 提交的預估入學人數: | 03/22/2020 |
| 首次發布: | 03/24/2020 |
| 上次提交的更新: | 03/22/2020 |
| 最近更新發布: | 03/24/2020 |
| 實際學習開始日期: | 05/31/2020 |
| 預計主要完成日期: | 05/31/2022 |
| 預計完成日期: | 05/31/2023 |
狀況或疾病
干預/治療
Drug: Vigabatrin
Drug: Placebo
相
手臂組
| 臂 | 干預/治療 |
|---|---|
| Experimental: Vigabatrin | Drug: Vigabatrin Vigabatrin - Pill, 500 mg twice daily for 7 days (days 0-6), 1000 mg twice daily for 7 days (days 7-13), 1500 mg twice daily for 10 days (days 14-23), 1000 mg twice daily for 7 days (days 24-30), 500 mg twice daily for 7 days (days 31-37) and will discontinue treatment on day 38. |
| Placebo Comparator: Placebo | Drug: Placebo Pill, 1 pill twice daily for 7 days (days 0-6), 2 pills twice daily for 7 days (days 7-13), 3 pills twice daily for 10 days (days 14-23), 2 pills twice daily for 7 days (days 24-30), 1 pill twice daily for 7 days (days 31-37) and will discontinue on day 38. |
資格標準
| 有資格學習的年齡 | 18 Years 至 18 Years |
| 有資格學習的性別 | All |
| 接受健康志願者 | 是 |
| 標準 | Inclusion Criteria: - age 25-60 years old - BMI 30.0-49.9 kg/m2 - IHTG content ≥5.6 - Homeostatic Model of Insulin Resistance (HOMA-IR) Score>2.5. Exclusion Criteria: - i) medical, surgical, or biological menopause; ii) previous bariatric surgery; iii) structured exercise ≥250 min per week (e.g., brisk walking); iv) unstable weight (>4% change during the last 2 months before entering the study); v) significant organ system dysfunction (e.g., diabetes, severe pulmonary, kidney or cardiovascular disease); vi) cancer; vii) polycystic ovary syndrome; viii) major psychiatric illness; ix) conditions that render subject unable to complete all testing procedures (e.g., severe ambulatory impairments, limb amputations, or metal implants that interfere with imaging procedures; coagulation disorders); x) regular use of tobacco products; xi) excessive consumption of alcohol (≥3 drinks/day for men and ≥2 drinks/day for women); xii) use of medications that are known to affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued for this study; xiii) pre-exisiting visual field deficits; xiv) pregnant or lactating women; xv) conditions that render subject unable to complete all testing procedures (e.g. aversion to needles, metal implants that prevent magnetic resonance imaging); xvi) persons who are unable or unwilling to follow the study protocol; and xvii) persons who are not able to grant voluntary informed consent |
結果
主要結果指標
1. Insulin Sensitivity [3 weeks after initiation of treatment]
次要成果指標
1. Oral Glucose Tolerance [3 weeks after initiation of treatment]
