Abstract No. 1784-P
Improvement in Glycemic Control, Lipids and Insulin Sensitivity
with the Combination of Chromium Picolinate and Biotin in Type 2
Diabetes Mellitus
Authors: CESAR ALBARRACIN, BURCHAM FUQUA, JEFF
GEOHAS, MANLEY FINCH, JAMES R. KOMOROWSKI
Institutions: Corpus Christi, TX; Chicago, IL; Purchase, NY
Results: Recent clinical trials suggest chromium
picolinate (CrPic), alone and in combination with biotin, improve
insulin sensitivity, glucose and lipid metabolism in type 2 DM (T2DM).
This 90-day, randomized, double blinded, placebo controlled multicenter
prospective study was designed to evaluate the effects of the combination
of CrPic and biotin on HbA1c, fasting plasma glucose (FPG), and
lipid profiles in patients with T2DM. Subjects were randomly assigned
in a 2:1 ratio to active (600 mcg Cr as CrPic and biotin 2 mg/per
day) or placebo. Fasting HbA1c, FPG, lipid profiles, and safety
information were collected at baseline and at the end of the study.
All analyses were conducted on the intent-to-treat (ITT) population
(N=368). ITT was defined as any subject who took at least one dose
and had one post baseline HbA1c measurement. ANCOVA was calculated
for the change in efficacy parameters with treatment as a factor
and the corresponding baseline variable as covariates. Model-adequate
least square means and 95% CIs for mean differences between the
treatment groups were calculated. Change in HbA1c (p<0.01), total
cholesterol (p<0.02), and TG/HDL (p<0.0001) were improved
in actives compared to placebo. In the active group but not placebo,
an increased effect in lowering HbA1c was seen in subjects with
higher baseline levels (>7%, -0.54%±0.08; >8%, -0.73%±0.1;
>9%, -1.17%±0.15; >10%, -1.78%±0.22; >11%, -1.96%±0.35).
At final visit, FPG levels were lower in active than placebo (159±3
mg/dL vs. 171±5 mg/dL; p<0.03). In subjects with baseline cholesterol
>200 mg/dL, total cholesterol (-19.11±4.2 mg/dL vs. ?5.87±5.6
mg/dL; p<0.06) and LDL -C (-21.7±4.5 mg/dL vs. ?8.2±3.7mg/dL;
p<0.02) were decreased in actives, not placebo. These results
suggest that the combination of CrPic and biotin may benefit individuals
with T2DM who are hyperglycemic and have dyslipidemia by reducing
the risk factors.
|