Home » Trials » SLCTR/2018/022


Effects of the LysulinTM supplementation on pre-diabetes: A randomized double-blind, placebo-controlled clinical trial -

SLCTR Registration Number

SLCTR/2018/022


Date of Registration

13 Jul 2018

The date of last modification

Jul 13, 2018



Application Summary


Scientific Title of Trial

Effects of the LysulinTM supplementation on pre-diabetes: A randomized double-blind, placebo-controlled clinical trial


Public Title of Trial

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


Disease of Health Condition(s) Studied

Pre-Diabetes


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

U1111-1214-5781


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

EC-18-020


Trial Details


What is the research question being addressed?

Does LysulinTM supplementation improve glycaemic control in patients with pre-diabetes?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Placebo


Assignment

Parallel


Purpose

Prevention


Intervention(s) planned

The study will be carried out at Nawaloka Hospital Research and Education Foundation (NHHEF), Nawaloka Hospitals PLC, Colombo, Sri Lanka.

Consenting participants meeting inclusion/exclusion criteria will be randomized into 2 arms using stratified block randomization.

Arm 1 (intervention arm) will receive a tablet containing LysulinTM supplementation (1130mg), to be taken orally three times daily for a period of 6 months. Each Lysulin tablet contains, Lysine (Amino acid) 1000mg, Zinc 10mg, Vitamin C 100mg and Magnesium stearate 20mg.

Arm 2 (control arm) will receive an identical matching placebo at the same frequency for the same duration. The placebo will be manufactured to have a similar appearance, shape, weight, and color as the LysulinTM tablet. The placebo tablet will contain rice flour (500mg), magnesium stearate (175mg), microcrystalline cellulose (425mg) and silicone (30mg).

The investigators, health care providers, patients and data collectors would be blinded to the treatment allocations.

Participants in both groups will receive uniform advice about diet and physical activity


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.



Primary outcome(s)

1) Change in HbA1c from baseline in treatment and placebo arms

2) Change in Fasting Plasma Glucose (FPG) from baseline in treatment and placebo arms

3) Change in 2-hour OGTT plasma glucose from baseline in treatment and placebo arms


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

1) At baseline

2) End of three months from starting therapy

3) End of study (6 months).


Secondary outcome

1) 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

2) Change in BMI and other anthropometric parameters (weight, waist circumference, hip circumference, waist:hip ratio) from baseline

3) Change in blood pressure (systolic and diastolic) from baseline 4) Change in the Lipid Profile (Total cholesterol, LDL, HDL and TAG) from baseline


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

1) 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

2) Change in BMI and other anthropometric parameters (weight, waist circumference, hip circumference, waist:hip ratio) from baseline

3) Change in blood pressure (systolic and diastolic) from baseline 4) Change in the Lipid Profile (Total cholesterol, LDL, HDL and TAG) from baseline



Target number/sample size

110 (55 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2018-07-17


Anticipated end date

2019-06-30


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee of the Faculty of Medicine, University of Colombo (Ref. No.: EC-18-020)


Funding source

Lysulin Inc, USA



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Ranil Jayawardena
Senior Lecturer
Department of Physiology, Faculty of Medicine, University of Colombo, No 25, Kynsey Road, Colombo 08, Sri Lanka
0112695300
0718323332

ranil@physiol.cmb.ac.lk
http://med.cmb.ac.lk/index.php/department-of-physiology-staff?id=234

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
0112695300
0772770202

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


Primary study sponsor/organization

Dr. Jhon Burd
Chief Executive Officer
4940, Bradshaw Court, San Diego, California, USA
619-992-2873

info@lysulin.com
https://lysulin.com/

Secondary study sponsor (If any)

None