The Effect of Lysulin on Glycemic Control and Advanced Glycation

Type 2 Diabetes Clinical Trial

Official title:

The Effect of Lysulin on Glycemic Control and Advanced Glycation in Inadequately Controlled Type 2 Diabetes Mellitus: a Double Blinded Placebo Controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04234581
• Other study ID #: 1185
• Status: Terminated
• Phase: N/A
• Start date: August 13, 2019
• Est. completion date: June 12, 2020

Study information

• Verified date: October 2020
• Source: Carl T. Hayden VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: June 12, 2020
• Est. primary completion date: June 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Lysulin
Participants will be randomly allocated for 3 months to LysulinTM (1,110 mg TID, i.e. 3.3 g/day) or matching placebo.

Locations

Country	Name	City	State
United States	Phoenix VA Healthcare System	Phoenix	Arizona
United States	Phoenix VA Medical Center	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Juraj Koska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting glucose	Fasting plasma glucose	Baseline
Primary	Fasting glucose	Fasting plasma glucose	6 weeks
Primary	Fasting glucose	Fasting plasma glucose	12 weeks
Primary	Hemoglobin A1c	Hemoglobin A1c measured by PVAHS pathology lab	Baseline
Primary	Hemoglobin A1c	Hemoglobin A1c measured by PVAHS pathology lab	12 weeks
Secondary	Fasting C-peptide	Plasma C-peptide measured by ELISA	Baseline
Secondary	Fasting C-peptide	Plasma C-peptide measured by ELISA	12 weeks
Secondary	CML	N?-carboxymethyl lysine in plasma	Baseline
Secondary	CML	N?-carboxymethyl lysine in plasma	12 weeks
Secondary	CEL	N?-carboxyethyl lysine in plasma	Baseline
Secondary	CEL	N?-carboxyethyl lysine in plasma	12 weeks
Secondary	GH1	Glyoxal hydroimidazolone in plasma	Baseline
Secondary	GH1	Glyoxal hydroimidazolone in plasma	12 weeks
Secondary	3DGH1	3-deoxyglucosone hydroimidazolone in plasma	Baseline
Secondary	3DGH1	3-deoxyglucosone hydroimidazolone in plasma	12 weeks
Secondary	MGH1	Methylglyoxal hydroimidazolone in plasma	Baseline
Secondary	MGH1	Methylglyoxal hydroimidazolone in plasma	12 weeks
Secondary	MetSO	Methionine sulfoxide in plasma	Baseline
Secondary	MetSO	Methionine sulfoxide in plasma	12 weeks
Secondary	2-AAA	2-aminoadipic acid in plasma	Baseline
Secondary	2-AAA	2-aminoadipic acid in plasma	12 weeks