the effect of lysulin on glycemic control and advanced glycation

Conditions: Type 2 Diabetes

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.

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).

Eligibility 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

Keywords: lysine vitamin c zinc hemoglobin a1c advanced glycation