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The Effect of Lysulin on Glycemic Control and Advanced Glycation

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ClinicalTrials.gov Identifier: NCT04234581
Recruitment Status : Terminated (Sponsor decision)
First Posted : January 21, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Juraj Koska, Carl T. Hayden VA Medical Center

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Dietary Supplement: Lysulin Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
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
Actual Study Start Date : August 13, 2019
Actual Primary Completion Date : June 12, 2020
Actual Study Completion Date : June 12, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

Placebo Comparator: Placebo
Subjects will be instructed to take two tablets of placebo per os with breakfast, lunch and dinner.
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.




Primary Outcome Measures :
  1. Fasting glucose [ Time Frame: Baseline ]
    Fasting plasma glucose

  2. Fasting glucose [ Time Frame: 6 weeks ]
    Fasting plasma glucose

  3. Fasting glucose [ Time Frame: 12 weeks ]
    Fasting plasma glucose

  4. Hemoglobin A1c [ Time Frame: Baseline ]
    Hemoglobin A1c measured by PVAHS pathology lab

  5. Hemoglobin A1c [ Time Frame: 12 weeks ]
    Hemoglobin A1c measured by PVAHS pathology lab


Secondary Outcome Measures :
  1. Fasting C-peptide [ Time Frame: Baseline ]
    Plasma C-peptide measured by ELISA

  2. Fasting C-peptide [ Time Frame: 12 weeks ]
    Plasma C-peptide measured by ELISA

  3. CML [ Time Frame: Baseline ]
    Nɛ-carboxymethyl lysine in plasma

  4. CML [ Time Frame: 12 weeks ]
    Nɛ-carboxymethyl lysine in plasma

  5. CEL [ Time Frame: Baseline ]
    Nɛ-carboxyethyl lysine in plasma

  6. CEL [ Time Frame: 12 weeks ]
    Nɛ-carboxyethyl lysine in plasma

  7. GH1 [ Time Frame: Baseline ]
    Glyoxal hydroimidazolone in plasma

  8. GH1 [ Time Frame: 12 weeks ]
    Glyoxal hydroimidazolone in plasma

  9. 3DGH1 [ Time Frame: Baseline ]
    3-deoxyglucosone hydroimidazolone in plasma

  10. 3DGH1 [ Time Frame: 12 weeks ]
    3-deoxyglucosone hydroimidazolone in plasma

  11. MGH1 [ Time Frame: Baseline ]
    Methylglyoxal hydroimidazolone in plasma

  12. MGH1 [ Time Frame: 12 weeks ]
    Methylglyoxal hydroimidazolone in plasma

  13. MetSO [ Time Frame: Baseline ]
    Methionine sulfoxide in plasma

  14. MetSO [ Time Frame: 12 weeks ]
    Methionine sulfoxide in plasma

  15. 2-AAA [ Time Frame: Baseline ]
    2-aminoadipic acid in plasma

  16. 2-AAA [ Time Frame: 12 weeks ]
    2-aminoadipic acid in plasma



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04234581


Locations
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United States, Arizona
Phoenix VA Healthcare System
Phoenix, Arizona, United States, 85012
Phoenix VA Medical Center
Phoenix, Arizona, United States, 85012
Sponsors and Collaborators
Juraj Koska
  Study Documents (Full-Text)

Documents provided by Juraj Koska, Carl T. Hayden VA Medical Center:
Informed Consent Form  [PDF] October 28, 2019

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Responsible Party: Juraj Koska, Senior Research Health Scientist, Carl T. Hayden VA Medical Center
ClinicalTrials.gov Identifier: NCT04234581    
Other Study ID Numbers: 1185
First Posted: January 21, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available on request. To protect the privacy and confidentiality of the research subjects, data will be de-identified by stripping all 18 HIPAA identifiers as comma-delimited text (.csv) files to ensure it is impossible to back out any changes and recover identifiable information.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: 3 years

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juraj Koska, Carl T. Hayden VA Medical Center:
lysine
vitamin C
zinc
hemoglobin A1c
advanced glycation
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases