The Effect of Lysulin on Glycemic Control and Advanced Glycation

NCT04234581 | Terminated

• 1 other identifier: 1185
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes

Keywords

lysine; vitamin C; zinc; hemoglobin A1c; advanced glycation

Outcome Measures

Primary Outcomes (5)

• Fasting glucose

  Fasting plasma glucose

  Baseline

• Fasting glucose

  Fasting plasma glucose

  6 weeks

• Fasting glucose

  Fasting plasma glucose

  12 weeks

• Hemoglobin A1c

  Hemoglobin A1c measured by PVAHS pathology lab

  Baseline

• Hemoglobin A1c

  Hemoglobin A1c measured by PVAHS pathology lab

  12 weeks

Secondary Outcomes (16)

• Fasting C-peptide

  Baseline

• Fasting C-peptide

  12 weeks

• CML

  Baseline

• CML

  12 weeks

• CEL

  Baseline

Study Arms (2)

Lysulin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Lysulin

Interventions

Lysulin DIETARY_SUPPLEMENT

Participants will be randomly allocated for 3 months to LysulinTM (1,110 mg TID, i.e. 3.3 g/day) or matching placebo.

Lysulin; Placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Juraj Koska: lead

Study Sites (2)

Phoenix VA Healthcare System

Phoenix, Arizona, 85012, United States

Location

Phoenix VA Medical Center

Phoenix, Arizona, 85012, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lysulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Research Health Scientist

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 21, 2020
• Study Start: August 13, 2019
• Primary Completion: June 12, 2020
• Study Completion: June 12, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 3 years

Locations

US (2)