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The Effect of Cinnamon Cassia on Diabetes Control and Cardiometabolic Risk Factors in Adults With Type 2 Diabetes Mellitus

NCT02942056 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-08-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cinnamon

Cinnamon tablets to treat type 2 DM

DRUG

placebo

placebo

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2020-01-31
Completion
2020-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02942056 on ClinicalTrials.gov