METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 69 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Biopsies
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether AMX0035 helps insulin work better and helps the parts of cells that make energy in adults with type 1 diabetes. Participants take AMX0035 or a placebo (a pill with no study drug) for 24 weeks.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 to 69, with type 1 diabetes for at least 1 year.
- Use insulin through daily shots or an insulin pump.
- Have an A1c below 9.5%. This test measures average blood sugar.
- Have a BMI of 18.5 to 40. BMI is a measure of weight compared with height.
- Take a steady dose of a RASB blood pressure medicine or a statin cholesterol medicine, if needed.
- Be willing and able to follow all study steps.
Who can't join
- Past pancreas disease or surgery; heart or blood vessel disease or stroke within 6 months; heart failure; severe swelling from fluid buildup; or a need to limit salt.
- Bile duct disease or conditions that change how bile acids move through the body; kidney filtering rate (eGFR) below 60; or liver disease with liver tests over 3 times the normal limit or severe liver damage.
- Pregnant, breastfeeding, or planning pregnancy during the study.
- Allergy to any study drug ingredient, or an abnormal ECG (a test of the heart's electrical activity).
- Use in the past month of medicines outside their approved use that affect how well insulin works, such as metformin; long-term blood thinner use; or use of certain other medicines that can affect the study drug. The study team must check your medicines.
- Very low blood sugar needing another person's help, or diabetic ketoacidosis (dangerous acid buildup from too little insulin), within the past 3 months.
- A personal or family history of breast or ovarian cancer.
- Taking part in another clinical trial, or any condition the study team and lead doctor decide makes joining unsafe.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Adults ≥18 years to \<70 years of age with established T1D (duration ≥1 year) 2. Currently on insulin therapy (multiple daily injections or insulin pump) 3. HbA1c \<9.5% 4. BMI 18.5-40 kg/m2 5. On stable dose of RASB or statin, if indicated 6. Willing and able to comply with all study procedures Exclusion Criteria: 1. History of pancreatic disease (including pancreatitis) or pancreatic surgery 2. History of cardiovascular disease or stroke within the past 6 months 3. History of heart failure per New York Heart Association criteria 4. History of severe edema or salt restriction requirement 5. Biliary disease or pathologies that may alter enterohepatic circulation of bile acids 6. Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m² 7. Liver disease (ALT/AST \>3x upper limit of normal \[ULN\]) or severe hepatic impairment (defined as Child-Pugh Class C) 8. Pregnancy, breastfeeding, or planning pregnancy during the study period 9. Known hypersensitivity to study drug components 10. Abnormal baseline ECG 11. Use of off label medications that affect insulin sensitivity within the past 1 month (e.g., metformin, GLP-1RA, SGLT2i, pioglitazone) 12. Chronic use of anticoagulants 13. 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 14. Use of substrates of CYP2C9, Organic Anion transporter 1, P-glycoprotein, and Breast Cancer Resistance Protein 15. History of severe hypoglycemia requiring assistance within the past 3 months 16. History of diabetic ketoacidosis (DKA) within the past 3 months 17. Personal or family history of breast cancer or ovarian cancer 18. Current participation in another clinical trial 19. Any condition(s) found by the study team and confirmed with the Investigator that make it unsafe to participate
Study sites (1)
WA
- University of Washington Medicine Diabetes Institute (UWMDI) · Seattle, WA 98109Amanda Bard, MMS, MS, CCRC · Study contact · 206-685-2069 · abard@uw.eduPetter Bjornstad, MD · Principal investigatorMore trials in Seattle