The Effect of Lysulin on Glycemic Control and Advanced Glycation

Not Applicable

Terminated

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Lysulin

• Registration Number: NCT04234581
• Lead Sponsor: Juraj Koska

Brief Summary

The primary objective is to determine whether 12 weeks of treatment with Lysulin, compared to placebo, causes a reduction from baseline in the plasma levels of glucose, hemoglobin A1c (HbA1c) and Advanced Glycation Endproducts (AGEs) in patients with inadequately controlled type 2 diabetes mellitus. Secondary objectives include determining whether 12 weeks of treatment with Lysulin increases beta-cell function as measured by plasma C-peptide levels.

Detailed Description

Objective(s): The primary objective is to determine whether 12 weeks of treatment with Lysulin, compared to placebo, causes a reduction from baseline in the plasma levels of glucose, hemoglobin A1c (HbA1c) and Advanced Glycation Endproducts (AGEs) in patients with inadequately controlled type 2 diabetes mellitus. Secondary objectives include determining whether 12 weeks of treatment with Lysulin increases beta-cell function as measured by plasma C-peptide levels.

Research Plan: A randomized, prospective, double-blind study with randomization to lysulin and placebo in a 1:1 fashion. The study will enroll 60 patients with inadequately controlled type 2 diabetes.

Methods: The study will be performed as outpatient study at Phoenix VA Clinical Research Center. The study will include 3-4 visits. At the initial visit, participants will complete informed consent proc HbA1c ≥ 7.5 % and \< 10%ess and undergo screening examination. Inclusion criteria will be age 21-75 years, HbA1c ≥ 7.5 % and \< 10%, and stable dose of insulin 6 weeks prior to enrollment. Qualified participants will be randomized to 3,330 mg/day Lysulin (1,110 mg tbl, TID) as add-on supplement therapy for 12 weeks. Follow-up visits will be at weeks 6 and week 12 (end of study). Baseline and follow-up visits will include physical examination, patient history and blood draw. The primary study outcome measure will be fasting plasma glucose and HbA1c. Secondary outcome measures will include fasting plasma C-peptide and AGE concentrations. A linear mixed effects model will be used to evaluate treatment-induced endpoints. The models will be fit for sequential values of the response variable (including the baseline measurement).

Study Timeline

• Study Start: 2019-08-13
• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-01-16
• Study First Posted: 2020-01-21
• Primary Completion: 2020-06-12
• Study Completion: 2020-06-12
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Type 2 diabetes mellitus
• HbA1c ≥7.5% and <10.0% within past 6 weeks on diet only or stable doses of oral antihyperglycemic agents with or without insulin
• stable body weight (< 5% change in last 3 months)
• If on insulin therapy: < 20% variation in insulin units 6 weeks prior to the study.

Exclusion Criteria

• Type 1 DM
• current or recent use of supplements containing lysine, zinc or vitamin C
• uncontrolled hypertension (blood pressure ≥160/90 mmHg)
• kidney disease (serum creatinine GFR ≤50 mL/min)
• major illness
• severe gastrointestinal disease
• pregnancy
• liver function tests > 2.5 times normal values in the past 3 months
• currently abusing alcohol or drugs, or have a history of alcohol or drug abuse that in the investigator's opinion could cause the subject to be non-compliant; or have a general history of non-compliance with medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lysulin	Lysulin	Participants will be randomly allocated in blocks for 3 months to LysulinTM (1,110 mg TID, i.e. 3.3 g/day) per os with breakfast, lunch and dinner.
Placebo	Lysulin	Subjects will be instructed to take two tablets of placebo per os with breakfast, lunch and dinner.

Primary Outcome Measures

Name	Time	Method
Fasting glucose	12 weeks	Fasting plasma glucose
Hemoglobin A1c	12 weeks	Hemoglobin A1c measured by PVAHS pathology lab

Secondary Outcome Measures

Name	Time	Method
CEL	12 weeks	Nɛ-carboxyethyl lysine in plasma
MetSO	12 weeks	Methionine sulfoxide in plasma
CML	12 weeks	Nɛ-carboxymethyl lysine in plasma
GH1	12 weeks	Glyoxal hydroimidazolone in plasma
Fasting C-peptide	12 weeks	Plasma C-peptide measured by ELISA
3DGH1	12 weeks	3-deoxyglucosone hydroimidazolone in plasma
MGH1	12 weeks	Methylglyoxal hydroimidazolone in plasma
2-AAA	12 weeks	2-aminoadipic acid in plasma

Trial Locations

Locations (2)

Phoenix VA Healthcare System; 🇺🇸 Phoenix, Arizona, United States

Phoenix VA Medical Center; 🇺🇸 Phoenix, Arizona, United States