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. 2021 Mar 26;100(12):e22272.
doi: 10.1097/MD.0000000000022272.

The efficacy of niacin supplementation in type 2 diabetes patients: Study protocol of a randomized controlled trial

Xiaoying Yan  1 , Shunyu Wang
Affiliations

The efficacy of niacin supplementation in type 2 diabetes patients: Study protocol of a randomized controlled trial

Xiaoying Yan et al. Medicine (Baltimore). .

Expression of concern in

  • Expression of Concern: Study Protocols.
    [No authors listed] [No authors listed] Medicine (Baltimore). 2025 Nov 7;104(45):e46330. doi: 10.1097/MD.0000000000046330. Medicine (Baltimore). 2025. PMID: 41204616 Free PMC article. No abstract available.

Abstract

Background: Dyslipidemia is a main risk factor of cardiovascular disease in the diabetic patients. Niacin was found acutely to decrease the plasma concentration of free fatty acids by inhibiting their mobilization from adipose tissue. This present study is a double blinded, randomized, and prospective trial to determine the effect of niacin during dyslipidemia in type 2 diabetic patients.

Methods: This randomized controlled, double-blinded, single center trial is carried out according to the principles of Declaration of Helsinki. This present study was approved in institutional review committee of the Second Affiliated Hospital of Dalian Medical University. All the patients received the informed consent. Diabetic patients were randomized (1:1) to receive 3-month treatment with extended-release niacin or matching placebo. The major outcome of our present study was the change in the level of HbA1c from the baseline to week 12. Secondary outcome measures contained the levels of fasting blood glucose, the concentrations of serum transaminase, the other laboratory variables, and self-reported adverse events. The P < .05 was regarded as statistically significant.

Results: We assumed that adding the niacin to the medication in patients with type 2 diabetes would reduce dyslipidemia and achieve target lipid levels.

Trial registration: This study protocol was registered in Research Registry (researchregistry5925).

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Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Flow diagram of the study.
See this image and copyright information in PMC

References

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