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

Phase 2

Conditions: Type 2 Diabetes Mellitus

Registration Number: SLCTR/2017/010

Lead Sponsor: niversity of Colombo

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: Not specified

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline in treatment and placebo arms<br> [At baseline and monthly for a period of four months.]<br>Change in Fasting Blood Glucose (FBG) from baseline in treatment and placebo arms [At baseline and monthly for a period of four months.]<br>

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with HbA1c <7.0% [At baseline and monthly for a period of four months.]<br> Percentage of patients with FBG < 126 mg/dl [At baseline and monthly for a period of four months. ]<br>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). [At baseline and monthly for a period of four months. ]<br>Change in BMI and other anthropometric parameters (weight, waist circumference, hip circumference, waist:hip ratio) from baseline [At baseline and monthly for a period of four months. ]<br>Change in Blood Pressure (systolic and diastolic) from baseline [At baseline and monthly for a period of four months. ]<br>Change in the Lipid Profile (Total cholesterol, LDL, HDL and TAG) from baseline [At baseline and monthly for a period of four months. ]<br>