STAR Study Investigating Performance and Safety of the Medical Device SiPore15™
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03823027|
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : March 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|PreDiabetes Pre Diabetes Prediabetic State Type2 Diabetes Type2 Diabetes Mellitus Overweight Obese||Device: SiPore15™||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The single-arm study is designed to collect data on changes over time, i.e. comparing the pre-treatment/baseline value with the value achieved after full treatment (12 weeks). Thus, each individual act as his/her own control. The study design has been discussed with notified bodies, and deemed appropriate as there is no state-of-the-art pharmacotherapy for treatment of prediabetes to compare with.|
|Masking:||None (Open Label)|
|Official Title:||Open-label, Single-arm, Multicenter Study Investigating Performance and Safety of SiPore15™ in Obese and Overweight Subjects With Prediabetes or Newly Diagnosed Type 2 Diabetes|
|Actual Study Start Date :||January 28, 2019|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||December 2019|
The device will be taken before three daily main meals togteher with water. The dose will be escalated from 1g per main meal to the full dose of 3g per main meal. The device is provided in foil stick-packs packed in boxes with weekly supply. The treatment is for 12 weeks.
SiPore15™ is a taste- and odourless white powder, consisting of precisely engineered micrometre sized synthetic amorphous silicon dioxide. The device is made of pure silicon dioxide, SiO2, which has the CAS Number: 112926-00-8 and EC List number: 601-214-2.
- Performance measured as changes in HbA1c [ Time Frame: From week 1 to week 12 ]To measure change in long-term blood glucose levels, HbA1c, from baseline (week 1) to end- -of-treatment (week 12).
- Tolerability measured as evaluation of Adverse Events [ Time Frame: From week 1 to week 14 ]To assess safety and tolerability by evaluating the frequency and incidence of both adverse events (AEs) and device related adverse events (ADEs) during the study treatment and follow-up, from baseline (week 1) until week 14.
- Performance measured as changes in LDL-C [ Time Frame: From week 1 to week 12 ]To measure change in LDL-C blood levels from baseline (week 1) to week 6 and end-of- treatment (week 12).
- Performance measured as changes in body fat % [ Time Frame: From week 1 to week 12 ]To measure change in body fat levels (bio electric impedance, BIA) from baseline (week 1) to week 6 and end-of-treatment (week 12).
- Exploratory Endpoint on Medical Device Usability [ Time Frame: From week 1 to week 12 ]
To assess Medical Device Usability by collecting data:
a. Collect information on Ease of use (Easy, neither/nor, difficult) at visit week 2, 6 and end-of -treatment.
- Explorative Endpoint on changes in Cholesterol [ Time Frame: From week 1 to week 12 ]To measure change in total Cholesterol levels from baseline to week 6 and end-of-treatment.
- Explorative Endpoint on changes in microbiome diversity (species not defined) [ Time Frame: From week 1 to week 24 ]To explore changes in microbiome by feces sampling for research at baseline and at week 24.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823027
|Contact: Kirsi Pietiläinen, Prof.||+358 (0) 2941 firstname.lastname@example.org|
|Pihlajalinna Ite, Satucon OY||Recruiting|
|Kuopio, Finland, 70100|
|Contact: Sakari Nieminen, MD email@example.com|
|Contact: Laura Jääskeläinen, Nurse +358 40 774 1104 firstname.lastname@example.org|
|Clinical Trial Consultants||Recruiting|
|Uppsala, Uppland, Sweden, 752 37|
|Contact: Erik Rein-Hedin, MD email@example.com|
|Contact: Gabriella Seger, Nurse +46 72 3659087 firstname.lastname@example.org|
|Study Chair:||Kirsi Pietiläinen, Prof.||Gyllenberg Professor in Clinical Metabolism Obesity Research Unit University of Helsinki|