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Effectiveness of Cinnamomum zeylanicum (Ceylon cinnamon) in lowering blood glucose in type 2 diabetes mellitus: a Randomized Double Blind Placebo Controlled Clinical Trial -

SLCTR Registration Number

SLCTR/2017/010


Date of Registration

05 Apr 2017

The date of last modification

Jun 20, 2017



Application Summary


Scientific Title of Trial

Effectiveness of Cinnamomum zeylanicum (Ceylon cinnamon) in lowering blood glucose in type 2 diabetes mellitus: a Randomized Double Blind Placebo Controlled Clinical Trial


Public Title of Trial

Effect of Ceylon cinnamon in lowering blood glucose for type 2 diabetes mellitus


Disease of Health Condition(s) Studied

Type 2 Diabetes Mellitus


Scientific Acronym

None


Public Acronym

None


Brief title

Ceylon cinnamon in type 2 diabetes


Universal Trail Number

U1111-1194-6431


Any other number(s) assigned to the trial and issuing authority

EC-16-197 (ERC: Colombo)


Trial Details


What is the research question being addressed?

Does Ceylon cinnamon lower blood glucose in patients with type 2 Diabetes Mellitus?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Placebo


Assignment

Parallel


Purpose

Treatment


Intervention(s) planned

The study will be carried out at Medical Clinics of the University Medical Unit, National Hospital of Sri Lanka.

Consenting participants meeting inclusion/exclusion criteria will be randomized into 3 arms using stratified block randomization.

Arm 1 (intervention arm) will receive a capsule containing 250mg Cinnamomum zeylanicum extract as the active ingredient, to be taken orally once daily before breakfast for a period of 4 months.

Arm 2 (intervention arm) will receive a capsule containing 500mg Cinnamomum zeylanicum extract as the active ingredient, to be taken orally once daily before breakfast for a period of 4 months.

Arm 3 (control arm) will receive an identical matching placebo. The placebo will be manufactured to have a similar appearance, shape, weight, and color as the cinnamon capsules

The investigators and patients would be blind to the treatment allocations.

Standard management will continue for participants in all 3 arms.


Inclusion criteria

  1. Male and female patients aged 18 – 70 years
  2. Diagnosed type 2 diabetes mellitus during the last 5 years
  3. Currently only on metformin or a sulphonyluria or both for the last 3 months
  4. HbA1c 6.5-8.0%
  5. Fasting blood glucose (FBG) 126-200 mg/dl

Exclusion criteria

  1. Known allergy to cinnamon.
  2. Alcohol consumption >20g/day
  3. Diagnosed Alcoholic Liver Disease, cirrhosis or abnormal baseline liver function tests.
  4. Patients who are currently on hypoglycemic agents other than metformin or a sulphonyluria)
  5. Insulin therapy
  6. Raised baseline serum creatinine level (>1.5mg/dl in males or >1.2 mg/dl in females)
  7. Lactation, pregnancy or unwillingness to use an effective form of birth control for women of child bearing years.
  8. Symptoms suggestive of peptic ulcer disease
  9. Past history of peptic ulceration.
  10. Any diagnosed malignancy
  11. Cardiac, liver or respiratory failure
  12. Any other unrelated chronic illness
  13. Any condition in the opinion of the primary investigator that would contraindicate the patient's participation.


Primary outcome(s)

  1. Change in HbA1c from baseline in treatment and placebo arms
  2. Change in Fasting Blood Glucose (FBG) from baseline in treatment and placebo arms

Primary outcome(s) - Time of assessment(s)

At baseline and monthly for a period of four months.


Secondary outcome

  1. Percentage of patients with HbA1c <7.0%
  2. Percentage of patients with FBG < 126 mg/dl
  3. Change in insulin resistance and Beta-cell function from baseline (measured by the Homeostasis Model of Assessment (HOMA) calculations based on fasting blood glucose and fasting serum insulin).
  4. Change in BMI and other anthropometric parameters (weight, waist circumference, hip circumference, waist:hip ratio) from baseline
  5. Change in Blood Pressure (systolic and diastolic) from baseline
  6. Change in the Lipid Profile (Total cholesterol, LDL, HDL and TAG) from baseline

Secondary outcome(s) - Time of assessment(s)

  1. Percentage of patients with HbA1c <7.0%
  2. Percentage of patients with FBG < 126 mg/dl
  3. Change in insulin resistance and Beta-cell function from baseline (measured by the Homeostasis Model of Assessment (HOMA) calculations based on fasting blood glucose and fasting serum insulin).
  4. Change in BMI and other anthropometric parameters (weight, waist circumference, hip circumference, waist:hip ratio) from baseline
  5. Change in Blood Pressure (systolic and diastolic) from baseline
  6. Change in the Lipid Profile (Total cholesterol, LDL, HDL and TAG) from baseline


Target number/sample size

210 (70 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2017-05-01


Anticipated end date

2017-12-31


Recruitment status

Pending


State of ethics review approval

Approved (Ethics Review Committee of the Faculty of Medicine, University of Colombo, on 23.3.2017 (Ref. No.: EC-16-197)


Funding source

University of Colombo (Grant ref. no. AP/03/2012/CG/08)



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Prof. Priyadarshani Galappatthy
Professor in Pharmacology
Department of Pharmacology, Faculty of Medicine, University of Colombo, No 25, Kynsey Road, Colombo 08, Sri Lanka
Tel: 0112695300
Mob: 0718655651

p.galappatthy@pharm.cmb.ac.lk
http://med.cmb.ac.lk/index.php/department-of-parmacol-staff?id=264

Contact Person for Public Queries

Dr. Priyanga Ranasinghe
Lecturer
Department of Pharmacology, Faculty of Medicine, University of Colombo, No 25, Kynsey Road, Colombo 08, Sri Lanka
Tel: 0112695300
Mob: 0772770202

priyanga@pharm.cmb.ac.lk
http://med.cmb.ac.lk/index.php/department-of-parmacol-staff?id=269


Primary study sponsor/organization

University of Colombo

Kumaratunga Munidasa Mawatha, Colombo 03 Sri Lanka
Tel: 0112581835

acpbuoc@gmail.com
http://www.cmb.ac.lk/

Secondary study sponsor (If any)

None