ECE2019 ePoster Presentations Diabetes, Obesity and Metabolism (42 abstracts)
1Endocrinology and Nutrition Dpt, Hospital Universitario de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria, Spain; 2Primary Healthcare Center, Arucas, Las Palmas, Spain; 3Outpatient Hypertension Clinic, Hospital Universitario de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria, Spain.
Aim: To establish the effect of a supplement containing 250 mg red yeast rice extract, 525 mg berberine and 50 mg coenzyme Q10 on insulin sensitivity in patients with hypercholesterolemia and prediabetes.
Methods: For this open, uncontrolled study, patients of age 3075 years, with hypercholesterolemia (LDL cholesterol >130 mg/dl and triglycerides <300 mg/dl), and prediabetes without overt cardiovascular disease, untreated in the previous 6 months were recruited. Insulin sensitivity was estimated by the HOMA2 calculator (https://www.dtu.ox.ac.uk/homacalculator/), at baseline and after 24 months of supplementation with the referred supplement once daily.
Results: 29 patients were recruited, age 57.6±10.9 years, 16 women (55%), No patients were lost to follow-up, but only 26 (90%) of the patients reported adequate compliance (>80%). None of the patients reported adverse effects attributed to the supplement, or had AST, ALT or CK > 3× upper normal limit. None of the patients developed type 2 diabetes, and 4 of them (14%) no longer maintained criteria for prediabetes. The HOMA2 Insulin Resistance Index was significantly reduced and the full results are presented in Table 1.
Parameters | Baseline | After supplementation | Change % | P- value |
HOMA2-IR index | 3.72±0.7 | 2.95±0.6 | −22% | < 0.01 |
Fasting Insulin (mU/l) | 13.7±3.6 | 11.4±3.7 | −17% | < 0.01 |
Fasting glycemia (mg/dL) | 112±10 | 106±7 | −5% | NS |
HbA1C (%) | 5.9±0.3 | 5.6±0.3 | −5% | NS |
LDL-cholesterol (mg/dL) | 172.2±33.6 | 133.5±21.9 | −21% | < 0.001 |
Total cholesterol total (mg/dL) | 254.4±47.9 | 215.3±38.6 | −15% | 0.008 |
HDL-cholesterol (mg/dL) | 39.6±8.1 | 43.6±9.2 | +10% | NS |
Triglycerides (mg/dL) | 218.8±68.6 | 191.0±75.3 | −13% | NS |
AST (U/L) | 41.2±10.9 | 36.8±10.3 | −11% | NS |
ALT (U/L) | 35.8±8.7 | 33.5±8.9 | −6% | NS |
GGT (U/L) | 65.4±16.2 | 61.1±15.4 | −7% | NS |
CK (U/L) | 98.1±15.9 | 98.6±14.4 | +0% | NS |
Estimated GFR CKD-EPI (ml/min/1.73m2) | 72.5±12.6 | 74.6±11.6 | +3% | NS |
BMI (kg/m2) | 28.8±4.8 | 28.6±4.3 | −1%, | NS |
SBP (mmHg) | 141±10 | 138±11 | −2% | NS |
DBP (mmHg) | 81±8 | 80±6 | −1% | NS |
HR (bpm) | 76±7 | 77±9 | +1% | NS |
Conclusions: Supplementation with red yeast rice extract, berberine and coenzyme Q10 in patients with hypercholesterolemia and prediabetes significantly reduced their total and LDL-cholesterol, as expected, without tolerance issues. Progression to type 2 diabetes was not observed. The patients were clearly insulin resistant at baseline, with high HOMA2 index, but their insulin resistance was significantly reduced with the supplementation. This effect could be expected to reduce their long term risk of progression to type 2 diabetes.