The Effect of Lysulin on Glycemic Control and Advanced Glycation

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Lysulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lysulin<br>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. | Dietary Supplement: Lysulin<br>* Participants will be randomly allocated for 3 months to LysulinTM (1,110 mg TID, i.e. 3.3 g/day) or matching placebo.<br>|
| Placebo Comparator: Placebo<br>Subjects will be instructed to take two tablets of placebo per os with breakfast, lunch and dinner. | Dietary Supplement: Lysulin<br>* Participants will be randomly allocated for 3 months to LysulinTM (1,110 mg TID, i.e. 3.3 g/day) or matching placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose | Fasting plasma glucose | Baseline | 
| Fasting glucose | Fasting plasma glucose | 6 weeks | 
| Fasting glucose | Fasting plasma glucose | 12 weeks | 
| Hemoglobin A1c | Hemoglobin A1c measured by PVAHS pathology lab | Baseline | 
| Hemoglobin A1c | Hemoglobin A1c measured by PVAHS pathology lab | 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lysine, vitamin C, zinc, hemoglobin A1c, advanced glycation