Loading clinical trials...

Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes

Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes Mellitus

NCT03396484•National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

View on ClinicalTrials.gov

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.

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).

Eligibility

Age

8 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Key Dates

Start Date

September 1, 2020

Primary Completion Date

March 1, 2022

Completion Date

March 1, 2022

Last Updated

June 30, 2020

Conditions

Type1 Diabetes Mellitus

Interventions

Methyldopa

DRUG

Placebo

DRUG

Continuous Monitoring of Glycemic Variability to Predict Dys- and Hyperglycemia in Asymptomatic Type 1 Diabetes

NCT05777330

Type1 Diabetes Mellitus

View study

RECRUITING

China Diabetes Registry by Metabolic Management Center

NCT03811470

Type 2 Diabetes MellitusType1 Diabetes Mellitus+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 30, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes

Inclusion Criteria

Exclusion Criteria

Continuous Monitoring of Glycemic Variability to Predict Dys- and Hyperglycemia in Asymptomatic Type 1 Diabetes

China Diabetes Registry by Metabolic Management Center

Role of Glucagon-like Peptide-1 Receptor Agonists in Menstrual Irregularities in Adolescent Females With Type 1 Diabetes Mellitus

The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes

Comparison of Real-time CGMS With Intermittently-scanned CGMS in Adolescents and Adults With Type 1 Diabetes Mellitus

The International Diabetes Closed Loop (iDCL) Trial: Protocol 1