Home » Trials » SLCTR/2018/022
Effects of the LysulinTM supplementation on pre-diabetes: A randomized double-blind, placebo-controlled clinical trial
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SLCTR Registration Number
SLCTR/2018/022
Date of Registration
The date of last modification
Mar 03, 2019
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
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
On any other vitamin or mineral supplementation
The current use of a weight loss medicine or dietary modification
History of diabetes mellitus
Presently having acute diseases requiring treatment (too numerous and diverse to be named individually)
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
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 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/
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
