Clinical Trial With Broccoli Sprout Extract to Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Sulforaphane binds to Keap1 in the cytosol, leading to nuclear translocation of this
      transcription factor. In the nucleus NRF2 induces the expression of a large number of
      anti-oxidative genes. Sulforaphane is contained at high concentration in broccoli sprout
      extracts (BSE). Human studies have been conducted using broccoli sprout products without
      complication. It is being tested for the treatment or prevention of cancer and inflammatory
      diseases in ~30 clinical trials without any serious adverse events reported. The low toxicity
      makes BSE ideal as a dietary supplement for preventing and treating T2D.

      The investigators aim to study the clinical effect of sulforaphane on glucose tolerance in
      T2D patients. Sulforaphane will be given as BSE. BSE is a freeze-dried powder of an aqueous
      extract of broccoli sprouts that provides a consistent and stable source of sulforaphane. The
      investigators will use a parallel arm study design with patients receiving BSE or placebo.
      The randomization will be double-blind. The study will be done at one centre. Patients with
      BMI between 25-40 kg/m2 will be included. Another inclusion criterion is HbA1c 6-10%.
      Patients will be treated for 12 weeks to enable us to observe effects on HbA1c (HbA1c
      turn-over is 3 months).

      Patients will come to a screening visit and if they give informed consent and are included
      they attend a second visit 2-3 weeks later.

      The patients will undergo an oral glucose tolerance test (OGTT) before and after the 12-week
      treatment period. The reason for using OGTT rather than e.g. insulin clamps as the readout is
      that it is a harmless standard procedure that gives an integrated view of glucose tolerance.
    

Intervention name(s): sulforaphane; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): sulforaphane-containing broccoli sprout extracts; Maltodextrine-based placebo without sulforaphane
Intervention MeSH terms: Sulforaphane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment