Effects of a combination supplement containing Lysine, Vitamin C and Zinc on oxidative stress, glycaemic control and formation of Advanced Glycosylation End Products (AGEs) in patients with type 2 diabetes mellitus: A randomized double-blind, placebo-controlled clinical trial
- Conditions
- Diabetes
- Registration Number
- SLCTR/2020/020
- Lead Sponsor
- Dr. Jhon Burd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
a) Age between 20-70 years
b) Both male and female
c) Currently on metformin or sulphonyluria or both (less than or equal to two oral hypoglcaemic agents) for the last 3 months
d) HbA1c > 7.5%
a) Patients with allergy to any ingredients of the supplement.
b) Alcohol consumption >20g/day.
c) Patients with diagnosed Alcoholic Liver Disease, cirrhosis or abnormal baseline liver function tests.
d) Patients on insulin therapy.
e) Patients with raised baseline serum creatinine level (>1.5mg/dl in males or >1.2 mg/dl in females).
f) Lactation, pregnancy or unwillingness to use an effective form of birth control for women of childbearing years.
g) Patients with any malignancy.
h) Patients with any other unrelated chronic illness.
i) Patients with cardiac, liver or respiratory failure.
j) Patients on any other vitamin/mineral supplementations or any other weight loss medication.
k) 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<br>End of 3 months<br>End of study (at 6 months)]<br>Change in Fasting Blood Glucose (FBG) from baseline in treatment and placebo arms [At baseline<br>End of 3 months<br>End of study (at 6 months)]<br>Change in formation of Advanced Glycosylation End Products (AGEs) from baseline in treatment and placebo arms [At baseline<br>End of 3 months<br>End of study (at 6 months) ]<br>Change in Oxidative Stress from baseline in treatment and placebo arms [At baseline<br>End of 3 months<br>End of study (at 6 months) ]<br>
- Secondary Outcome Measures
Name Time Method Percentage of patients with HbA1c <7.0% in treatment and placebo arms [At baseline<br>End of study (at 6 months)]<br>Percentage of patients with Fasting Blood Glucose (FBG) level < 126 mg/dl in treatment and placebo arms<br> [At baseline<br>End of study (at 6 months)]<br>Change in insulin resistance and Beta-cell function in treatment and placebo arms measured by Homeostatic model assessment [At baseline<br>End of study (at 6 months)]<br>Change in Body Mass Index and other anthropometric parameters (waist circumference, hip circumference, waist-to-hip ratio) in treatment and placebo arms [At baseline<br>End of study (at 6 months)]<br>Change in Blood Pressure (systolic and diastolic) in treatment and placebo arms [At baseline<br>End of study (at 6 months)]<br>Change in the Lipid Profile (Total cholesterol, LDL cholesterol, HDL cholesterol and Triglycerides) in treatment and placebo arms [At baseline<br>End of study (at 6 months)]<br>