Type 2 Diabetes Mellitus
Conditions
Interventions
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
Sponsors
University of Colombo
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline in treatment and placebo arms [At baseline and monthly for a period of four months.] Change in Fasting Blood Glucose (FBG) from baseline in treatment and placebo arms [At baseline and monthly for a period of four months.] | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with HbA1c <7.0% [At baseline and monthly for a period of four months.] Percentage of patients with FBG < 126 mg/dl [At baseline and monthly for a period of four months. ] 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. ] 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. ] Change in Blood Pressure (systolic and diastolic) from baseline [At baseline and monthly for a period of four months. ] Change in the Lipid Profile (Total cholesterol, LDL, HDL and TAG) from baseline [At baseline and monthly for a period of four months. ] | — |
Countries
Sri Lanka
Contacts
Public ContactProf. Priyadarshani Galappatthy
Professor in Pharmacology
Outcome results
None listed