A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Metformin Therapy in Overweight/Obese Youth with Type 1 Diabetes
| Autor: | Jody Fleshman, Lisa Greenman, Benjamin U. Nwosu, Bruce A. Barton, Louise Maranda, Mary M. Lee, Karen Cullen, Nancy McShea |
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| Rok vydání: | 2015 |
| Předmět: |
Adult
Blood Glucose Male medicine.medical_specialty endocrine system diseases Adolescent medicine.medical_treatment Placebo-controlled study lcsh:Medicine Overweight Insulin resistance Double-Blind Method Internal medicine Diabetes mellitus medicine Humans Insulin Obesity lcsh:Science Child Glycemic Glycated Hemoglobin Type 1 diabetes Multidisciplinary business.industry lcsh:R nutritional and metabolic diseases medicine.disease Metformin Endocrinology Diabetes Mellitus Type 1 Chemotherapy Adjuvant lcsh:Q Female medicine.symptom business medicine.drug Research Article |
| Zdroj: | PLoS ONE PLoS ONE, Vol 10, Iss 9, p e0137525 (2015) |
| ISSN: | 1932-6203 |
| Popis: | Context Insulin resistance has been proposed as one of the causes of poor glycemic control in overweight/obese youth with type 1 diabetes (T1D). However, the role of adjunctive metformin, an insulin sensitizer, on glycemic control in these patients is unclear. Objective To compare the effect of metformin vs. placebo on hemoglobin A1c (HbA1c), total daily dose (TDD) of insulin, and other parameters in overweight/obese youth with T1D. Hypothesis Adjunctive metformin therapy will improve glycemic control in overweight/obese youth with T1D. Design, Setting, and Participants A 9-mo randomized, double-blind, placebo controlled trial of metformin and placebo in 28 subjects (13m/15f) of ages 10-20years (y), with HbA1c >8% (64 mmol/mol), BMI >85%, and T1D > 12 months was conducted at a university outpatient facility. The metformin group consisted of 15 subjects (8 m/ 7f), of age 15.0 ± 2.5 y; while the control group was made up of 13 subjects (5m/ 8f), of age 14.5 ± 3.1y. All participants employed a self-directed treat-to-target insulin regimen based on a titration algorithm of (-2)-0-(+2) units to adjust their long-acting insulin dose every 3rd day from -3 mo through +9 mo to maintain fasting plasma glucose (FPG) between 90–120 mg/dL (5.0–6.7 mmol/L). Pubertal maturation was determined by Tanner stage. Results Over the course of the 9 months of observation, the between-treatment differences in HbA1c of 0.4% (9.85% [8.82 to 10.88] for placebo versus 9.46% [8.47 to 10.46] for metformin) was not significant (p = 0.903). There were non-significant reduction in fasting plasma glucose (189.4 mg/dL [133.2 to 245.6] for placebo versus 170.5 mg/dL [114.3 to 226.7] for metformin), (p = 0.927); total daily dose (TDD) of short-acting insulin per kg body weight/day(p = 0.936); and the TDD of long-acting insulin per kg body weight per day (1.15 units/kg/day [0.89 to 1.41] for placebo versus 0.90 units/kg/day [0.64 to 1.16] for metformin) (p = 0.221). There was no difference in the occurrence of hypoglycemia between the groups. Conclusions This 9-month RCT of adjunctive metformin therapy in overweight and obese youth with T1D resulted in a 0.4% lower HbA1c value in the metformin group compared to the placebo group. Trial Registration ClinicalTrial.gov NCT01334125 |
| Databáze: | OpenAIRE |
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