Type 2 DiabetesNCT04234581
The Effect of Lysulin on Glycemic Control and Advanced Glycation
A study testing Lysulin in people with Type 2 Diabetes, run by Juraj Koska at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Lysulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Aug 2019to 12 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Phoenix VA Healthcare System
Phoenix, Arizona, 85012
Phoenix VA Medical Center
Phoenix, Arizona, 85012
About this study
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
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.
Read the 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).
- Conditions
- Type 2 Diabetes
- Being tested
- Lysulin
- Keywords
- lysine, vitamin C, zinc, hemoglobin A1c, advanced glycation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LysulinDietary supplement
Participants will be randomly allocated for 3 months to LysulinTM (1,110 mg TID, i.e. 3.3 g/day) or matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Lysulin |
| Placebo | Placebo comparator | Subjects will be instructed to take two tablets of placebo per os with breakfast, lunch and dinner. Receives: Dietary Supplement: Lysulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glucose
Fasting plasma glucose
Measured: Baseline
Fasting glucose
Fasting plasma glucose
Measured: 6 weeks
Fasting glucose
Fasting plasma glucose
Measured: 12 weeks
Hemoglobin A1c
Hemoglobin A1c measured by PVAHS pathology lab
Measured: Baseline
Hemoglobin A1c
Hemoglobin A1c measured by PVAHS pathology lab
Measured: 12 weeks
Secondary outcomes (16)
Fasting C-peptide
Plasma C-peptide measured by ELISA
Measured: Baseline
Fasting C-peptide
Plasma C-peptide measured by ELISA
Measured: 12 weeks
CML
Nɛ-carboxymethyl lysine in plasma
Measured: Baseline
CML
Nɛ-carboxymethyl lysine in plasma
Measured: 12 weeks
CEL
Nɛ-carboxyethyl lysine in plasma
Measured: Baseline
CEL
Nɛ-carboxyethyl lysine in plasma
Measured: 12 weeks
GH1
Glyoxal hydroimidazolone in plasma
Measured: Baseline
GH1
Glyoxal hydroimidazolone in plasma
Measured: 12 weeks
3DGH1
3-deoxyglucosone hydroimidazolone in plasma
Measured: Baseline
3DGH1
3-deoxyglucosone hydroimidazolone in plasma
Measured: 12 weeks
MGH1
Methylglyoxal hydroimidazolone in plasma
Measured: Baseline
MGH1
Methylglyoxal hydroimidazolone in plasma
Measured: 12 weeks
MetSO
Methionine sulfoxide in plasma
Measured: Baseline
MetSO
Methionine sulfoxide in plasma
Measured: 12 weeks
2-AAA
2-aminoadipic acid in plasma
Measured: Baseline
2-AAA
2-aminoadipic acid in plasma
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start13 Aug 2019
- Primary completion12 Jun 2020
- Study completion12 Jun 2020
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juraj Koska
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Juraj Koska, Carl T. Hayden VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234581
- Sponsor's protocol ID
- 1185
- Status last verified
- Oct 2020
- First submitted
- 16 Jan 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on request. To protect the privacy and confidentiality of the research subjects, data will be de-identified by stripping all 18 HIPAA identifiers as comma-delimited text (.csv) files to ensure it is impossible to back out any changes and recover identifiable information.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04234581
- Acronym / sponsor ID
- 1185
- Conditions
- Type 2 Diabetes
- Keywords
- lysine, vitamin C, zinc, hemoglobin A1c, advanced glycation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Juraj KoskaUS federal agency
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lysulin | Experimental | Dietary Supplement: LysulinParticipants 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. |
| Placebo | Placebo comparator | Dietary Supplement: LysulinSubjects will be instructed to take two tablets of placebo per os with breakfast, lunch and dinner. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LysulinParticipants will be randomly allocated for 3 months to LysulinTM (1,110 mg TID, i.e. 3.3 g/day) or matching placebo. | Dietary supplement | Lysulin, Placebo |
Primary outcome
Fasting glucose
Time frame: Baseline
Fasting plasma glucose
Fasting glucose
Time frame: 6 weeks
Fasting plasma glucose
Fasting glucose
Time frame: 12 weeks
Fasting plasma glucose
Hemoglobin A1c
Time frame: Baseline
Hemoglobin A1c measured by PVAHS pathology lab
Hemoglobin A1c
Time frame: 12 weeks
Hemoglobin A1c measured by PVAHS pathology lab
16 secondary outcomes
Fasting C-peptide
Time frame: Baseline
Fasting C-peptide
Time frame: 12 weeks
CML
Time frame: Baseline
CML
Time frame: 12 weeks
CEL
Time frame: Baseline
CEL
Time frame: 12 weeks
GH1
Time frame: Baseline
GH1
Time frame: 12 weeks
3DGH1
Time frame: Baseline
3DGH1
Time frame: 12 weeks
MGH1
Time frame: Baseline
MGH1
Time frame: 12 weeks
MetSO
Time frame: Baseline
MetSO
Time frame: 12 weeks
2-AAA
Time frame: Baseline
2-AAA
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: Yes. Data will be available on request. To protect the privacy and confidentiality of the research subjects, data will be de-identified by stripping all 18 HIPAA identifiers as comma-delimited text (.csv) files to ensure it is impossible to back out any changes and recover identifiable information.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lysulin in people with Type 2 Diabetes, run by Juraj Koska at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting glucose (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.