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• Status: Withdrawn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: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University

Criteria

Inclusion Criteria:

• Males and females ages 30-65 years of age

• Diagnosed Type 2 diabetes with a HbA1c of 6.5-9%, treated with either lifestyle alone or with metformin

• Weight stable for 3 months as defined by no greater than a 5% change.

Exclusion Criteria:

• Pregnancy

• Breast feeding

• Use of any other diabetes treatment other than metformin within the past 3 months

• Type 1 diabetes

• HbA1c > 9% or less than< 6.5%

• Liver disease with a known diagnosis of cirrhosis

• Liver Dysfunction with AST or ALT liver enzymes > 2x upper limit of normal

• Chronic Kidney Disease with glomerular filtration rate < 45 ml/min/1.73m2

• Anemia with hematocrit < 30%

• TSH > 5 or < 0.4 mIU/L

• Coagulopathy, INR > 1.3

• Use of warfarin or other new oral anticoagulants (dabigatran, rivaroxaban, apixaban)

• Use of subcutaneous heparin, enoxaparin, dalteparin

• Use of class 1 or class 3 anti-arrhythmic medications (disopyramide, procainamide, quinidine, mexilitine, flecanide, propafenone, amiodarone, sotalol, dronedarone, dofetilide)

• Use of immunosuppressants (methotrexate, prednisone, tacrolimus, sirolimus, azathioprine, mycophenolate, cyclosporine)

• Chronic use of benzodiazepines (midazolam, alprazolam, lorezepam, temezepam, diazepam, clonazepam, chlordiazepoxide) for the past 3 months

• Chronic use of medications that may affect body weight, glucose or lipid metabolism (e.g., anti-psychotics, anti-seizure, weight loss meds) for the past 3 months

• Patients with celiac sprue or gluten sensitive individuals

• Self-report of > 3 alcoholic drinks per day

• Congestive heart failure (ejection fraction < 45%)