N/A
N=39
[11C]5-Hydroxy-tryptophan PET for Assessment of Islet Mass in Type 2 Diabetes
Type2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02967354 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: [11C]5-hydroxy-tryptophan Uptake in the Pancreas — 0.17; 0.21; 0.20; 0.23 % of injected dose — p=0.5875
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan (Radiation)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Per-Ola Carlsson
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY [11C]5-hydroxy-tryptophan Uptake in the Pancreas |
0.17; 0.21; 0.20; 0.23; 0.15 | 0.5875 |
| SECONDARY Pancreatic Perfusion |
84.37; 134.90; 107.72; 72.20; 59.82 | 0.0065 sig |
| SECONDARY Pancreatic Volume |
67.68; 88.54; 98.96; 64.1; 53.39 | 0.0072 sig |
| SECONDARY Pancreatic Fat Content |
11.33; 11.54; 8.75; 9.58; 9.72 | 0.9472 |
| SECONDARY Hepatic Fat Content |
5.30; 14.40; 13.42; 5.50; 9.01 | 0.0048 sig |
Summary
Cross-sectional study to investigate subjects at different stages of type 2 diabetes development with expected stratification of pancreatic islet mass. Non-diabetic individuals were assigned as control. The primary outcome was the [11C]5-hydroxy-tryptophan uptake and retention in the pancreas as a surrogate marker for the endogenous islet mass.
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes fulfilling criteria for the four different study groups, or healthy volunteers
Exclusion Criteria
- Ongoing pregnancy
- Renal failure (GFR<60 ml/min)
- Magnetic metal parts in the body
- Ongoing treatment with selective serotonin receptor inhibitors
Data sourced from ClinicalTrials.gov (NCT02967354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.