NCT02942056

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Typical duration for phase_2 diabetes-mellitus

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

October 20, 2016

Last Update Submit

August 2, 2019

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Type 2 DM control

    change in HbA1c

    6 months

Secondary Outcomes (2)

  • lipid control

    6 months

  • obesity

    6 months

Study Arms (2)

Study Drug

EXPERIMENTAL

Randomized to cinnamon cassia 750 mg TID for 6 months. Assess HbA1c and CV risk profile

Drug: Cinnamon

Placebo

PLACEBO COMPARATOR

Randomized to placebo matching tablet TID for 6 months. Assess HbA1c and CV risk profile

Drug: placebo

Interventions

CinnamonDRUG

Cinnamon tablets to treat type 2 DM

Study Drug
placeboDRUG

placebo

Placebo

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 21, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

August 6, 2019

Record last verified: 2019-08