Insulin sensitizer in prediabetes: a clinical study with DLBS3233, a combined bioactive fraction of Cinnamomum burmanii and Lagerstroemia speciosa.
BACKGROUND
The aim of this paper is to evaluate the efficacy and safety of DLBS3233, a novel bioactive fraction derived from Cinnamomum burmanii and Lagerstroemia speciosa, in improving insulin resistance and preserving β-cell performance in patients with impaired glucose tolerance (IGT).


METHODS
Eighty adult subjects with IGT, defined as 2-hour postprandial glucose level of 140-199 mg/dL, were enrolled in this two-arm, 12-week, double-blind, randomized, placebo-controlled preliminary study. Eligible subjects were randomly allocated to receive either DLBS3233 at a dose of 50-100 mg daily or placebo for 12 weeks. The study mainly assessed the improvement of homeostatic model-assessed insulin resistance (HOMA-IR), the 15-minute and 2-hour plasma insulin levels, and the oral disposition index.


RESULTS
After 12 weeks, DLBS3233 improved insulin resistance better than placebo as reflected by a reduced HOMA-IR (-27.04%±29.41% vs -4.90%±41.27%, P=0.013). The improvement of the first- and second-phase insulin secretion was consistently greater in DLBS3233 group than placebo group (-144.78±194.06 vs -71.21±157.19, P=0.022, and -455.03±487.56 vs -269.49±467.77, P=0.033, respectively). Further, DLBS3233 also significantly better improved oral disposition index than placebo. No serious hypoglycemia, edema, or cardiovascular-related adverse events were found in either groups.


CONCLUSIONS
This study has shown that DLBS3233 at the dose of 50-100 mg once daily was well tolerated, and promisingly efficacious in improving insulin sensitivity as well as preserving β-cell performance in subjects with IGT.
Department of Internal Medicine, Faculty of Medicine, University of Andalas, Dr M Djamil Padang Hospital, Padang, Indonesia.
Asman
A
Manaf
Dexa Laboratories of Biomolecular Sciences (DLBS), Cikarang, Indonesia.
Raymond R
RR
Tjandrawinata
Department of Internal Medicine, Faculty of Medicine, University of Andalas, Dr M Djamil Padang Hospital, Padang, Indonesia.
Desi
D
Malinda
D000293:Adolescent; D000328:Adult; D027424:Cinnamomum / Q000737:chemistry*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D018149:Glucose Intolerance / Q000188:drug therapy*; D006801:Humans; D007004:Hypoglycemic Agents / Q000737:chemistry / Q000302:isolation & purification / Q000627:therapeutic use*; D007328:Insulin / Q000378:metabolism*; D007333:Insulin Resistance; D031563:Lagerstroemia / Q000737:chemistry*; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000737:chemistry / Q000302:isolation & purification / Q000627:therapeutic use*; D011236:Prediabetic State; D011446:Prospective Studies; D055815:Young Adult
C000613148:DLBS3233; D007004:Hypoglycemic Agents; D007328:Insulin; D010936:Plant Extracts
Cinnamomum burmanii; DLBS3233; Lagerstroemia speciosa; impaired glucose tolerance; insulin resistance; β-cell function