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Trial record 94 of 401 for:    PYY

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

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ClinicalTrials.gov Identifier: NCT02942056
Recruitment Status : Withdrawn (Could not obtain appropriate funding or standardized manufacturing for cinnamon tablets)
First Posted : October 21, 2016
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Scott M. Chadderdon, Oregon Health and Science University

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Cinnamon Drug: placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Cinnamon Cassia on Diabetes Control and Cardiometabolic Risk Factors in Adults With Type 2 Diabetes Mellitus
Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Drug
Randomized to cinnamon cassia 750 mg TID for 6 months. Assess HbA1c and CV risk profile
Drug: Cinnamon
Cinnamon tablets to treat type 2 DM

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




Primary Outcome Measures :
  1. Type 2 DM control [ Time Frame: 6 months ]
    change in HbA1c


Secondary Outcome Measures :
  1. lipid control [ Time Frame: 6 months ]
    change in LDL, HDL, triglycerides

  2. obesity [ Time Frame: 6 months ]
    change in abdominal fat percentage



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%)

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Responsible Party: Scott M. Chadderdon, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02942056     History of Changes
Other Study ID Numbers: OHSU IRB # 11386
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases