Lack of effect of sucralose on glucose homeostasis in subjects with type 2 diabetes

  • V.L. G
  • R.R. H
  • J.B. M
 et al. 
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Abstract

Objective: To investigate the effect of 3-months' daily administration of high doses of sucralose, a non-nutritive sweetener, on glycemic control in subjects with type 2 diabetes. Design: A multicenter, double-blind, placebo-controlled, randomized study, consisting of a 6-week screening phase, a 13-week test phase, and a 4-week follow-up phase. Subjects/setting: Subjects with type 2 diabetes (age range 31 to 70 years) entered the test phase of this study; 128 subjects completed the study. The subjects were recruited from 5 medical centers across the United States and were, on average, obese. Intervention: Subjects were randomly assigned to receive either placebo (cellulose) capsules (n=69) or 667 mg encapsulated sucralose (n=67) daily for the 13-week test phase. All subjects blindly received placebo capsules during the last 4 weeks of the screening phase and for the entire 4-week follow-up phase. Main outcome measures: Glycated hemoglobin (HbA1c), fasting plasma glucose, and fasting serum C-peptide were measured approximately every 2 weeks to evaluate blood glucose homeostasis. Data were analyzed by analysis of variance using repeated measures. Results: There were no significant differences between the sucralose and placebo groups in HbA1c, fasting plasma glucose, or fasting serum C-peptide changes from baseline. There were no clinically meaningful differences between the groups in any safety measure. Conclusions: This study demonstrated that, similar to cellulose, sucralose consumption for 3 months at doses of 7.5 mg/kg/day, which is approximately three times the estimated maximum intake, had no effect on glucose homeostasis in individuals with type 2 diabetes. Additionally, this study showed that sucralose was as well-tolerated by the study subjects as was the placebo.

Author-supplied keywords

  • *diabetes mellitus
  • *glucose homeostasis
  • *glucose/ec [Endogenous Compound]
  • *non insulin dependent diabetes mellitus
  • *sucralose
  • C peptide
  • C peptide/ec [Endogenous Compound]
  • United States
  • adult
  • analysis of variance
  • article
  • cellulose
  • controlled study
  • data analysis
  • diet restriction
  • disease control
  • drug megadose
  • encapsulation
  • female
  • follow up
  • food intake
  • glucose
  • glucose blood level
  • glycemic control
  • glycosylated hemoglobin
  • glycosylated hemoglobin/ec [Endogenous Compound]
  • health center
  • hemoglobin A1c
  • human
  • major clinical study
  • male
  • measurement
  • non insulin dependent diabetes mellitus
  • obesity
  • patient
  • patient selection
  • placebo
  • protein blood level
  • randomization
  • safety
  • screening
  • serum
  • sweetening agent

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Authors

  • Grotz V.L.

  • Henry R.R.

  • Mcgill J.B.

  • Prince M.J.

  • Shamoon H.

  • Trout J.R.

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