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Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes (TN-23)

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ClinicalTrials.gov Identifier: NCT03396484
Recruitment Status : Not yet recruiting
First Posted : January 11, 2018
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:
A study is to see if methyldopa can change the immune system's attack on insulin producing cells in people at early stages of type 1 diabetes.

Condition or disease Intervention/treatment Phase
Type1 Diabetes Mellitus Drug: Methyldopa Drug: Placebo Phase 2

Detailed Description:

The study is a randomized, double blinded, placebo-controlled, multi-center crossover clinical trial.

Eligible subjects will be randomized in a 1:1 allocation ratio to one of two treatment schedules: first methyldopa then placebo vs. first placebo then methyldopa.

The study objective is to assess the safety, efficacy, and mode of action of methyldopa to reduce DQ8 antigen presentation in individuals at Stage 1 and 2 of type 1 diabetes (T1D).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes Mellitus
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Methyldopa

Adults: methyldopa 500mg twice daily for one week and then increased to 500mg three times a day

Children: methyldopa dose based on weight twice daily for one week then increased to three times a day

Drug: Methyldopa
Tablet for oral dosing
Other Name: Aldomet

Placebo Comparator: Placebo
Inactive agent to match active drug in appearance and dose frequency.
Drug: Placebo
Tablet for oral dosing




Primary Outcome Measures :
  1. DQ8 Antigen Presentation [ Time Frame: 6 months after initiation of treatment ]
    insulin peptide-specific DQ8 antigen presentation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant in TrialNet Pathway to Prevention Study (TN01)
  • Willing to provide Informed Consent or, if the subject is <18 years of age, have a parent or legal guardian provide Informed Consent
  • Confirmed positive for one or more autoantibodies, one of which is insulin autoantibody (mIAA)
  • Positive for at least one gene encoding HLA-DQ8 (DQB*0302)
  • If a female participant with reproductive potential, willing to avoid pregnancy and undergo pregnancy testing prior to randomization and during the study
  • Have normal or abnormal glucose tolerance on OGTT performed within 7 weeks of randomization

Exclusion Criteria:

  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol
  • History of clinically significant anemia or Hemoglobin <10 g/dl
  • Evidence of liver dysfunction
  • History of renal insufficiency
  • History of symptomatic hypotension including positional hypotension
  • Systolic BP < 100 mmHg for adults or blood pressure < 5th percentile for age/height/gender in children and adolescents
  • Use of a treatment that is known to cause a significant, ongoing change in the course of diabetes or immunologic status, within 4 weeks prior to participation. This includes high-dose inhaled, extensive topical or systemic glucocorticoids
  • Females who are pregnant at the time of screening, breastfeeding or unwilling to defer pregnancy during the 16-month study period. (Female participant must be at least 100 days postpartum before enrollment into study)
  • Unable to avoid concurrent antihypertensive medications, monoamine oxidase (MAO) inhibitors, lithium, or medications containing ferrous sulfate or ferrous gluconate
  • Unable to avoid medications that affect stomach pH, such as proton pump inhibitors or histamine H2 receptor blockers
  • Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396484


Contacts
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Contact: Lisa Rafkin 305-243-6146 lrafkin@miami.edu
Contact: Ryan O'Donnell 813-396-9551 Ryan.O'Donnell@epi.usf.edu

Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Study Chair: Carla Greenbaum, MD Type 1 Diabetes TrialNet

Additional Information:
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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT03396484     History of Changes
Other Study ID Numbers: Methyldopa
UC4DK106993 ( U.S. NIH Grant/Contract )
UC4DK117009 ( U.S. NIH Grant/Contract )
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
TrialNet

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Methyldopa
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action