Clinical Trial With Broccoli Sprout Extract to Patients With Type 2 Diabetes

• Status: Active, not recruiting
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Type 2 diabetes (T2D) results from a combination of insufficient insulin secretion from pancreatic islets and insulin resistance of target cells. The investigators have extensive pre-clinical data suggesting that BSE through its high content of the isothiocyanate sulforaphane improves hepatic insulin sensitivity. BSE as a dietary supplement could therefore benefit both patients with T2D and individuals at risk for the disease. BSE-containing sulforaphane is suggested to activate Nuclear factor-like 2 (NRF2). The investigators aim to study the clinical effect of using BSE as a dietary supplement on glucose tolerance and insulin sensitivity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anders Rosengren, MD PhD
• Treatments: Sulforafan; Sulforaphane

Criteria

Inclusion Criteria:

• Classified as type 2 diabetes

• Written informed consent

• Age: for men and women 35-75 years; for women below 75 years should be postmenopausal (defined as no menstrual bleeding since at least one year).

• Body mass index 25-40 kg/m2

• At screening visit : HbA1c 6-10 %, equivalent to 41-86 mmol/mol

• Currently treated with metformin or diet

Exclusion Criteria:

• Treatment with insulin, other anti-diabetic treatment given as injections or any oral anti-diabetic treatment except metformin

• Fasting blood glucose at screening > 15.0 mmol/L

• Active liver disease

• At screening or at any subsequent visit a level of aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) of more than three times the upper limit of the normal range

• Gastrointestinal ailments which may interfere with the ability to adequately absorb sulforaphane

• At screening visit creatinine > 130 µmol/L

• Coagulation disorder or current anti-coagulant therapy with warfarin, which may be affected by the BSE

• Diagnosed with a cardiovascular disease or event within 6 months prior to enrolment

• Systemic glucocorticoid treatment

• Herbal treatment, defined as food supplement (except multivitamin treatment) with herbal or vegetable extracts that may contain sulforaphane

• Allergy to broccoli

• Mental disorder making the patient unable to understand the study information

• Participation in other clinical trial which may affect the outcome of the present study

• Any other physical or psychiatric condition or treatment that in the judgment of the investigator makes it difficult to participate in the study.