BridgeMD
Role of BCAA in glucose homeostasis
EU CTIS ID: 2023-503424-12-00
What this study is testing
The primary objective is to investigate if prolonged boosting of BCAA oxidation will substantially lower fasting plasma glucose levels in patients with T2D.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients are able to provide signed and dated written informed consent prior to any study specific procedures
- No signs of active liver or kidney malfunction
- Women are post-menopausal (defined as at least 1 year post cessation of menses) and aged ≥ 45 and ≤ 76 years. Males are aged ≥ 40 years and ≤ 76 years
- Patients should have suitable veins for cannulation or repeated venipuncture
- Caucasians
- BMI: 25-38 kg/m2
You likely can't join if
- Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator
- Participate in physical activity more than 3 times a week
- Unstable body weight (weight gain or loss > 5 kg in the last three months)
- Insulin dependent T2D
- Patients with congestive heart failure and and/or severe renal and or liver insufficiency or known sodium retention with oedema
- Patients using Probalan (probenecid), Haldol (haloperidol), Depakene (valproate) or medical products containing corticosteroids
See the full eligibility criteria
- Patients are able to provide signed and dated written informed consent prior to any study specific procedures
- No signs of active liver or kidney malfunction
- Women are post-menopausal (defined as at least 1 year post cessation of menses) and aged ≥ 45 and ≤ 76 years. Males are aged ≥ 40 years and ≤ 76 years
- Patients should have suitable veins for cannulation or repeated venipuncture
- Caucasians
- BMI: 25-38 kg/m2
- Diagnosed with T2D at least 1.5 years before the start of the study
- Relatively well-controlled T2D: HbA1c < 8.5%
- Oral glucose lowering medication: metformin only or in combination with sulfonylurea agents and/or on stable dose of a DPPIV inhibitor treatment for at least the last 3 months
- No signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy
- Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator
- Participate in physical activity more than 3 times a week
- Unstable body weight (weight gain or loss > 5 kg in the last three months)
- Insulin dependent T2D
- Patients with congestive heart failure and and/or severe renal and or liver insufficiency or known sodium retention with oedema
- Patients using Probalan (probenecid), Haldol (haloperidol), Depakene (valproate) or medical products containing corticosteroids
- Men: Hb <8.4 mmol/L, Women: Hb <7.8 mmol/l
- Any contra-indication MRI scanning. These contra-indications include patients with e.g. the following: • Central nervous system aneurysm clip • Implanted neural stimulator • Implanted cardiac pacemaker of defibrillator • Cochlear implant • Metal containing corpora aliena in the eye or brains
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.