The Effect of Cinnamon Cassia on Diabetes Control and Cardiometabolic Risk Factors in Adults With Type 2 Diabetes Mellitus
Status:
Withdrawn
Trial end date:
2020-01-01
Target enrollment:
Participant gender:
Summary
The overall goal of this proposal is to establish the efficacy of cinnamon for the treatment
of T2DM. Additional aims will assess the effect of cinnamon on cardiovascular risk factors
and explore novel potential mechanisms of action leading to improved insulin sensitivity.
Based on previously published animal and human data we have hypothesized that six months
treatment with Cinnamon cassia supplementation (2.25 grams/day) will improve glycemic control
and cardio-metabolic risk factors. We believe these benefits may be mediated in part through
improved insulin mediated capillary recruitment and skeletal muscle vasodilators leading to
reduced insulin resistance. We will achieve our goal through completion of the following
aims:
Aim 1. To demonstrate the efficacy, safety, and tolerability of oral cinnamon use (750 mg
three times daily) to improve glucose control. The primary outcome will be determined as a
reduction in hemglobin A1c (HbA1c) level of at least 0.5% compared to placebo.
Aim 2. To quantify effects of oral cinnamon (vs. placebo) on cardio-metabolic risk factors,
including: fasting levels of plasma insulin and glucose, homeostatic model assessment of
insulin resistance (HOMA-IR), lipids (total, VLDL, LDL, HDL cholesterol; triglyceride), free
fatty acids, as well whole body, abdominal, and visceral adiposity as measured with dual
energy x-ray absorptiometry (DEXA) imaging.
Aim 3. In this mechanistic exploratory aim, potential gastrointesitnal effects will be
assessed as follows: a 3-hour oral glucose tolerance test (OGTT) with blood samples collected
for insulin, glucose, C-peptide, glucagon, GLP-1, and GIP will be performed separately.
Additional biochemical markers (ghrelin, PYY, pro-insulin, apo B, adinopectin) will be
collected as well.