owering BCAA as a new strategy to improve insulin sensitivity

Completed

• Conditions: diabetes; insulin resistance; 10018424

• Registration Number: NL-OMON48748
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Trial ended prematurely

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

1. Patients are able to provide signed and dated written informed consent prior to any study specific procedures
2. Women are post-menopausal (defined as at least 1 year post cessation of menses) and aged >= 45 and <= 75 years. Males are aged >= 40 years and <= 75 years
3. Patients should have suitable veins for cannulation or repeated venipuncture
4. Caucasians
5. BMI: 25-38 kg/m2
6. Diagnosed with T2D at least 1.5 years before the start of the study
7. Relatively well-controlled T2D: HbA1c < 8.5%
8. 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
9. No signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy
10. No signs of active liver or kidney malfunction

Exclusion Criteria

1. Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator
2. Participate in physical activity more than 3 times a week
3. Unstable body weight (weight gain or loss > 5 kg in the last three months)
4. Insulin dependent T2D
5. Patients with congestive heart failure and and/or severe renal and or liver insufficiency or known sodium retention with oedema
6. Patients using Probalan (probenecid), Haldol (haloperidol), Depakene (valproate) or medical products containing corticosteroids
7. Men: Hb <8.4 mmol/L, Women: Hb <7.8 mmol/l
8. Any contra-indication MRI scanning. These contra-indications include patients with following devices:
• Central nervous system aneurysm clip
• Implanted neural stimulator
• Implanted cardiac pacemaker of defibrillator
• Cochlear implant
• Metal containing corpora aliena in the eye or brains

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Whole-body insulin sensitivity measured upon both treatment periods. Insulin<br /><br>sensitivity will be expressed as the change of insulin-stimulated rate of<br /><br>glucose disappearance (&Delta;Rd). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• muscle mitochondrial function<br /><br>• whole-body energy metabolism<br /><br>• fat accumulation in muscle and the liver </p><br>