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

Jan 28, 2019



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 or Health Condition(s) Studied

Pre-Diabetes


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial 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


Study Phase

Phase 4


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

    [

    At baseline

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

    [

    End of three months from starting therapy

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

    [

    End of study (6 months).

    ]

Secondary outcome(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

    [

    At baseline

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

    [

    End of three months from starting therapy

    ]
  3. 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).

    ]

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


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Lysulin Inc, USA


Regulatory approvals

Not applicable



State of Ethics Review Approval


Status

Approved


Date of Approval

2018-05-17


Approval number

EC-18-020


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Colombo
Institutional Address: No. 25, Kynsey Road, Colombo 00800 Sri Lanka
Telephone: +94-11-2695300 (Extension: 240)
Email: ethicscommitteemfc@gmail.com


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





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Not Available


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results