Clinical trial NCT04234581: The Effect of Lysulin on Glycemic Control and Advanced Glycation
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: lysine
vitamin C
zinc
hemoglobin A1c
advanced glycation
Lead sponsor: Carl T. Hayden VA Medical Center
Sponsor class: FED
First posted: 2020-01-21
Enrollment: 59
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Fasting glucose
timeFrame: Baseline
measure: Fasting glucose
timeFrame: 6 weeks
measure: Fasting glucose
timeFrame: 12 weeks
measure: Hemoglobin A1c
timeFrame: Baseline
measure: Hemoglobin A1c
timeFrame: 12 weeks
Secondary outcomes:
measure: Fasting C-peptide
timeFrame: Baseline
measure: Fasting C-peptide
timeFrame: 12 weeks
measure: CML
timeFrame: Baseline
measure: CML
timeFrame: 12 weeks
measure: CEL
timeFrame: Baseline
measure: CEL
timeFrame: 12 weeks
measure: GH1
timeFrame: Baseline
measure: GH1
timeFrame: 12 weeks
measure: 3DGH1
timeFrame: Baseline
measure: 3DGH1
timeFrame: 12 weeks
measure: MGH1
timeFrame: Baseline
measure: MGH1
timeFrame: 12 weeks
measure: MetSO
timeFrame: Baseline
measure: MetSO
timeFrame: 12 weeks
measure: 2-AAA
timeFrame: Baseline
measure: 2-AAA
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix VA Healthcare System
state: Arizona
city: Phoenix
country: United States
facility: Phoenix VA Medical Center
state: Arizona
Study officials:
References: