Division of Pediatric Endocrinology, Department of Pediatrics; Department of Quantitative Health Sciences
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Clinical trial identification number: ClinicalTrial.gov NCT01334125
This study was supported by an investigator-initiated research grant to Benjamin U. Nwosu from Novo Nordisk, Inc. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
type 1 diabetes mellitus, biguanides, metformin, insulin resistance, cardiovascular risk
This dataset is the primary data source for a manuscript submitted for publication.
Context: The cardiovascular effect of adjunctive metformin therapy in overweight/obese youth with type 1 diabetes (T1D) is unknown.
Objective: To compare the effect of prolonged, adjunctive metformin vs. placebo therapy on markers of cardiovascular risk in overweight/obese youth with T1D based on differences in total cholesterol (TC)/ high-density lipoprotein (HDL) ratio, triglycerides (TG)/HDL ratio, Atherogenic Index of Plasma (AIP) log [TG/HDL] ratio, adiponectin/leptin ratio, and 25-hydroxyvitamin D [25(OH)D] concentration.
Hypothesis: Adjunctive metformin therapy will improve markers of cardiovascular health in overweight/obese youth with T1D.
Setting: University outpatient facility.
Design and Participants: A 9-mo randomized, double-blind, placebo-controlled trial of metformin (1000 mg daily) and placebo in 28 subjects (13m/15f) of ages 10-20years (y), with HbA1c >8%, BMI >85%, and T1D > 12 months. The metformin group consisted of 15 subjects (8 m/7f), of age 15.0±2.5 y; while the control group consisted of 13 subjects (5m/8f), of age 14.5±3.1y. Participants employed a self-directed treat-to-target insulin regimen based on a titration algorithm of (-2)-0-(+2) units to adjust long-acting insulin dose every 3rd day from -3 mo through +9 mo to maintain fasting plasma glucose between 90-120 mg/dL.
Results: After adjusting for age, gender, BMI, and baseline values, the metformin group had a clinically significant reduction in TC/HDL of 0.5 unit: 3.5[3.0-4.1] vs. 4.0 [3.3-4.4] (p=0.578); and TG/HDL of 1.0 unit, 2.6 [1.1-4.3] vs. 3.6 [2.0-5.2] (p=0.476); and AIP of 0.44 unit: -0.23 ± 0.9 vs. 0.21 ± 0.8 (p=0.251). Conversely, the metformin group had a clinically significant elevation in adiponectin/leptin ratio of 0.8 unit: 2.0[0.84-3.2] vs. 1.2[0.11-2.3], (p=0.057); and a mean serum 25(OH)D in the vitamin D sufficiency range, 31.3 ng/mL [22.3-40.4] compared to the placebo group's lower mean 25(OH)D of 25.8 ng/mL [14.1-35.9], (p=0.337).
Conclusions: Prolonged adjunctive metformin therapy may be cardio-protective in overweight/obese youth with T1D.
The code list for this dataset is available under "Additional Files."
Nwosu BU, Maranda LS, Cullen K, Greenman L, Fleshman J, McShea N, Barton BA, Lee MM. (2015). Data from: The Cardiovascular Effects of Adjunctive Metformin Therapy in Overweight/obese Youth with Type 1 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Trial. Pediatric Research Data. https://doi.org/10.13028/M2H59X. Retrieved from https://escholarship.umassmed.edu/pediatrics_data/3
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.xlsx (54 KB)