Type 2 Diabetes
Conditions
Keywords
lysine, vitamin C, zinc, hemoglobin A1c, advanced glycation
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).
Interventions
DIETARY_SUPPLEMENTLysulin
Participants will be randomly allocated for 3 months to LysulinTM (1,110 mg TID, i.e. 3.3 g/day) or matching placebo.
Sponsors
Juraj Koska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting glucose | Baseline | Fasting plasma glucose |
| Hemoglobin A1c | Baseline | Hemoglobin A1c measured by PVAHS pathology lab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CEL | Baseline | Nɛ-carboxyethyl lysine in plasma |
| GH1 | Baseline | Glyoxal hydroimidazolone in plasma |
| 3DGH1 | Baseline | 3-deoxyglucosone hydroimidazolone in plasma |
| Fasting C-peptide | Baseline | Plasma C-peptide measured by ELISA |
| MetSO | Baseline | Methionine sulfoxide in plasma |
| 2-AAA | Baseline | 2-aminoadipic acid in plasma |
| MGH1 | Baseline | Methylglyoxal hydroimidazolone in plasma |
| CML | Baseline | Nɛ-carboxymethyl lysine in plasma |
Countries
United States
Outcome results
None listed