The Effect of Lysulin on Glycemic Control and Advanced Glycation
Study Details
Study Description
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 |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Fasting glucose [Baseline]
Fasting plasma glucose
- Fasting glucose [6 weeks]
Fasting plasma glucose
- Fasting glucose [12 weeks]
Fasting plasma glucose
- Hemoglobin A1c [Baseline]
Hemoglobin A1c measured by PVAHS pathology lab
- Hemoglobin A1c [12 weeks]
Hemoglobin A1c measured by PVAHS pathology lab
Secondary Outcome Measures
- Fasting C-peptide [Baseline]
Plasma C-peptide measured by ELISA
- Fasting C-peptide [12 weeks]
Plasma C-peptide measured by ELISA
- CML [Baseline]
Nɛ-carboxymethyl lysine in plasma
- CML [12 weeks]
Nɛ-carboxymethyl lysine in plasma
- CEL [Baseline]
Nɛ-carboxyethyl lysine in plasma
- CEL [12 weeks]
Nɛ-carboxyethyl lysine in plasma
- GH1 [Baseline]
Glyoxal hydroimidazolone in plasma
- GH1 [12 weeks]
Glyoxal hydroimidazolone in plasma
- 3DGH1 [Baseline]
3-deoxyglucosone hydroimidazolone in plasma
- 3DGH1 [12 weeks]
3-deoxyglucosone hydroimidazolone in plasma
- MGH1 [Baseline]
Methylglyoxal hydroimidazolone in plasma
- MGH1 [12 weeks]
Methylglyoxal hydroimidazolone in plasma
- MetSO [Baseline]
Methionine sulfoxide in plasma
- MetSO [12 weeks]
Methionine sulfoxide in plasma
- 2-AAA [Baseline]
2-aminoadipic acid in plasma
- 2-AAA [12 weeks]
2-aminoadipic acid in plasma
Eligibility Criteria
Criteria
Inclusion Criteria:
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Type 2 diabetes mellitus
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HbA1c ≥7.5% and <10.0% within past 6 weeks on diet only or stable doses of oral antihyperglycemic agents with or without insulin
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stable body weight (< 5% change in last 3 months)
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If on insulin therapy: < 20% variation in insulin units 6 weeks prior to the study.
Exclusion Criteria:
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Type 1 DM
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current or recent use of supplements containing lysine, zinc or vitamin C
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uncontrolled hypertension (blood pressure ≥160/90 mmHg)
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kidney disease (serum creatinine GFR ≤50 mL/min)
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major illness
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severe gastrointestinal disease
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pregnancy
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liver function tests > 2.5 times normal values in the past 3 months
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Phoenix VA Healthcare System | Phoenix | Arizona | United States | 85012 |
| 2 | Phoenix VA Medical Center | Phoenix | Arizona | United States | 85012 |
Sponsors and Collaborators
- Juraj Koska
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- 1185