Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effect of Broccoli Sprout Extract in Patients With Chronic Kidney Disease With Diabetes Type 2
This research project aims to test if sulforaphane, administered as broccoli sprout extract (BSE) can ameliorate glucose control in adult patients with chronic kidney disease (CKD) and DM 2 with GFR > 15 < 45 ml/min/1.73 m2. The glucose control will be evaluated by the oral glucose tolerance test. Moreover, as a secondary aim, we will investigate the role of sulforaphane in improving other signs of metabolic derangements present in this group of patients, including oxidate stress, proteinuria, inflammation and a decrease in the production of uremic toxins from the gut microbiota. This a multicentre randomized double-blinded controlled trial including 100 adult patients with CKD and glomerular filtration rate (GFR) between 15 and 29 ml/min/1.73m2, DM type 2, age > 18 years old. Patients will be randomized into BSE group or Placebo group. Both groups will be followed for 20 weeks: The first 12 weeks patients will receive the BSE or Placebo and, the next 8 weeks, both groups will be followed with no intervention to observe the changes in the primary and secondary outcomes. Patients randomized to BSE Group will receive 50 µmmol/day of sulforaphane administered as BSE (Lantmännen®) from week 0 to week 4. If no side-effects are reported, the sulforaphane dose will increase to 100 µmmol/day from week 5 to week 8 and in the absence of side-effects, the dose will increase to 150 µmmol/day from week 9 to week 12. Blood and urine samples and OGTT (in non-insulin dependent patients) will be performed at week 0, 12 and 20. On week 4 and 8 blood drawn for partial exam will be performed. The BSE and the placebo (maltodextrin sprayed with copper-chlorophyllin) will be administered as powder provided in a double-blind manner as dry mixtures in sealed portion size bags of similar shape and size. Randomization will be done using a computer-based block randomization algorithm. Comparisons between the primary and secondary studied variables will be done with two-way analysis of variance (ANOVA) with repeated measures for normally distributed variables. Variables that can interfere with the glycemic control, such as changes in the dosage of hypoglicemiants agents and insulin during the intervention will be controlled in the analysis. Those non-normally distributed will be log transformed aiming to normalize the distribution. All test will consider a P<0.05 for statistical significance. The software Stata will be used for the statistical analysis.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
|
||
| Completed |
NCT05647083 -
The Effect of Massage on Diabetic Parameters
|
N/A | |
| Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
| Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
| Completed |
NCT02836704 -
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
|
Phase 4 | |
| Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
| Completed |
NCT04562714 -
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
|
N/A | |
| Completed |
NCT02009488 -
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
| Completed |
NCT05896319 -
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
|
N/A | |
| Recruiting |
NCT05598203 -
Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes
|
N/A | |
| Completed |
NCT05046873 -
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
|
Phase 1 | |
| Terminated |
NCT04090242 -
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
|
N/A | |
| Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
| Completed |
NCT03604224 -
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
|
||
| Completed |
NCT03620357 -
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
|
N/A | |
| Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
| Completed |
NCT03620890 -
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
|
Phase 4 | |
| Withdrawn |
NCT05473286 -
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
|
||
| Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
| Completed |
NCT04531631 -
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
|
Phase 2 |