Идёт набор NCT07699380

METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)

Фаза II С лечением Type 1 Diabetes (T1D) Metabolic Diseases Glucose Metabolism Disorders Endocrine System Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: AMX0035, Placebo.
Кому может быть актуально: Состояния в реестре: Type 1 Diabetes (T1D), Metabolic Diseases, Glucose Metabolism Disorders, Endocrine System Diseases. Базовые параметры: 18 лет — 69 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Нидерланды
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The study is a randomized, double-blind, parallel-group clinical trial to examine the effects of 24 weeks of oral AMX0035 (sodium phenylbutyrate + taurursodiol) versus placebo in 60 adults with Type 1 Diabetes (T1D) (n=30 per arm). Enrollment will be distributed equally between the University of Washington and Amsterdam University Medical Center/Diabetes Center Amsterdam. Participants will be recruited through diabetes research registries, local T1D clinics, and community outreach.

Подробное описание

This is a randomized, double-blind, parallel-group clinical trial to evaluate the effects of 24 weeks of oral AMX0035 (sodium phenylbutyrate + taurursodiol) versus placebo in 60 adults with type 1 diabetes (T1D) (n=30 per arm). Following screening and baseline assessments, eligible participants will be randomized 1:1 to receive either AMX0035 or placebo, with stratification by sex and body mass index (≥30 vs. \<30 kg/m2). Participants will undergo comprehensive metabolic phenotyping at baseline and 24 weeks, including hyperinsulinemic-euglycemic clamp studies, body composition imaging, continuous glucose monitoring, and tissue biopsies (skeletal muscle and adipose) for assessment of mitochondrial function and biological markers. Participants, clinicians administering the intervention, and laboratory personnel analyzing the samples will remain blinded to treatment assignments throughout the study.

Вмешательства

Препарат AMX0035
AMX0035 sachets
Препарат Placebo
Placebo sachets

Первичные конечные точки

Change in whole-body insulin sensitivity (M-value) measured by hyperinsulinemic-euglycemic clamp [Срок оценки: Baseline, 24 weeks]

Вторичные конечные точки (5)

Changes in glycemic control [Срок оценки: Baseline, 24 weeks]
Changes in body composition [Срок оценки: Baseline, 24 weeks]
Changes in immune and metabolic biomarkers [Срок оценки: Baseline, 24 weeks]
Changes in mitochondrial function [Срок оценки: Baseline, 24 weeks]
Establish the safety and tolerability of AMX0035 in adults with T1D [Срок оценки: Duration of study]

Критерии участия

Критерии включения

Adults ≥18 years to <70 years of age with established T1D (duration ≥1 year)
Currently on insulin therapy (multiple daily injections or insulin pump)
HbA1c <9.5%
BMI 18.5-40 kg/m2
On stable dose of RASB or statin, if indicated
Willing and able to comply with all study procedures

Критерии исключения

History of pancreatic disease (including pancreatitis) or pancreatic surgery
History of cardiovascular disease or stroke within the past 6 months
History of heart failure per New York Heart Association criteria
History of severe edema or salt restriction requirement
Biliary disease or pathologies that may alter enterohepatic circulation of bile acids
Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m²
Liver disease (ALT/AST >3x upper limit of normal \[ULN\])
Pregnancy, breastfeeding, or planning pregnancy during the study period
Known hypersensitivity to study drug components
Abnormal baseline ECG
Use of off label medications that affect insulin sensitivity within the past 1 month (e.g., metformin, GLP-1RA, SGLT2i, pioglitazone)
Chronic use of anticoagulants
Use of bile acid sequestering agents, inhibitors of bile acid transporters, bile acid derivatives, aluminum-based antacids, probenecid, pan-HDAC inhibitors, phase 2 metabolizing enzymes (e.g., uridine diphosphate glucuronosyl transferases), phase 1 metabolizing enzymes other than cytochrome P450 enzymes (CYPs), and OATP1B3
Use of substrates of CYP1A2, CYP2C8, CYP2B6, CYP3A4, Organic Anion transporter 1, P-glycoprotein, and Breast Cancer Resistance Protein
History of severe hypoglycemia requiring assistance within the past 3 months
History of diabetic ketoacidosis (DKA) within the past 3 months
Personal or family history of breast cancer or ovarian cancer
Current participation in another clinical trial
Any condition(s) found by the study team and confirmed with the Investigator that make it unsafe to participate