Insulin clearance at randomisation and in response to treatment in youth with type 2 diabetes: a secondary analysis of the TODAY randomised clinical trial
Authors' conclusion
In youth with type 2 diabetes, low IC is correlated with female sex, non-Hispanic Black race and ethnicity, and markers of adiposity and insulin resistance, but not with beta cell function. Along with insulin sensitivity and adiponectin, IC increased in response to rosiglitazone treatment. These findings suggest that, in youth-onset type 2 diabetes, low IC is a compensatory response to changes in insulin sensitivity and/or adiponectin concentrations and is not a mediator of beta cell function.
Study context
- Population
- Youth aged 10–18 years with T2D
- Participants
- 640 participants
- Comparison
- Metformin vs metformin + lifestyle vs metformin + rosiglitazone; sex and race/ethnicity differences in insulin clearance
- Primary endpoint
- Insulin clearance (IC): fasting C-peptide:insulin ratio (fasting IC) and 2 h OGTT C-peptide incremental AUC (iAUC):insulin iAUC ratio (2 h IC)
- Follow-up
- Baseline and over 5 years
Methodological detailslongitudinal over 5 years
- Longitudinal over 5 years
Primary result
As reported in the abstract
Female vs Male: P = 0.04 · Non-Hispanic Black vs Hispanic and non-Hispanic White: P < 0.0001
Further findings
| Outcome | P value |
|---|---|
| IC by treatment · over timeMetformin+rosiglitazone vs Metformin · IC higher with metformin+rosiglitazone | P = 0.03 for fasting IC; p=0.02 for 2 h IC |
| IC by treatment · over timeMetformin+rosiglitazone vs Metformin+lifestyle · IC higher with metformin+rosiglitazone | 2 h IC, p=0.005 |
% change in insulin clearance (IC) per 5 kg weight increase over time
- Fasting IC, % change
- −1.52 [−2.05, −0.99] (95% CI)
- 2 h IC, % change
- −3.46 [−4.05, −2.86] (95% CI)
- Lower IC also correlated with other adiposity and insulin-sensitivity markers (higher BMI, subcutaneous adipose tissue (SAT), waist:height ratio, visceral adipose tissue (VAT), VAT:SAT, TG, TG:HDL-C, AST, ALT, systolic and diastolic BP; lower HDL-C and total and HMW adiponectin)
Prediction of persistently elevated blood glucose
- Beta cell function from OGTTs, not insulin sensitivity or IC, was predictive
IC by treatment · over time
- Not significant after adjusting for adiponectin
Original publication
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