Effect of LysulinTM supplementation on blood glucose control in pre-diabetes

Phase 4

Conditions: Pre-Diabetes

Registration Number: SLCTR/2018/022

Lead Sponsor: Dr. Jhon Burd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

a) Age between 18-60 years

b) Both male and female

c) Screening test confirming presence of pre-diabetes as defined by Fasting Plasma Glucose (FPG) between 100-125mg/dl (Impaired Fasting Glucose [IFG]) or 2-hr Post Oral Glucose Tolerance Test (OGTT) Plasma Glucose between 140-199mg/dl (Impaired Glucose Tolerance [IGT]) or both IFG and IGT or a HbA1c value between 6.0-6.4%.

Exclusion Criteria

1. On any other vitamin or mineral supplementation

2. The current use of a weight loss medicine or dietary modification

3. History of diabetes mellitus
4. Presently having acute diseases requiring treatment (too numerous and diverse to be named individually)

5. Impaired hepatic or renal functions

6.Patients with any malignancy or any other unrelated chronic illness, such as chronic kidney disease, ischaemic heart disease. Etc (again too numerous and diverse to be named individually)

7.Patients with cardiac, liver or respiratory failure

8.Any condition in the opinion of the primary investigator that would contraindicate the patient's participation

9.Allergy to any of the constituents of the investigational tablets.

10.Lactation

11.Pregnancy

12.Unwillingness to use an effective form of birth control for women of child bearing years.

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><br> [At baseline<br><br>]<br> Change in Fasting Plasma Glucose (FPG) from baseline in treatment and placebo arms [ End of three months from starting therapy]<br> Change in 2-hour OGTT plasma glucose from baseline in treatment and placebo arms [ End of study (6 months).]<br>

Secondary Outcome Measures

Name	Time	Method
Percentage of patients developing diabetes during follow-up, as indicated by either FPG >125mg/dL and/or 2-hour OGTT plasma glucose of >199mg/dL and/or HbA1C>6.5%, confirmed during follow-up visits [ At baseline]<br>Change in BMI and other anthropometric parameters (weight, waist circumference, hip circumference, waist:hip ratio) from baseline [ End of three months from starting therapy]<br>Change in blood pressure (systolic and diastolic) from baseline 4) Change in the Lipid Profile (Total cholesterol, LDL, HDL and TAG) from baseline [ End of study (6 months).]<br>