No registrations found.
ID
Source
Brief title
Health condition
diabetes mellitus
metabolic syndrome
obesitas
Intervention
Outcome measures
Primary outcome
• Glucose metabolism: HOMA-IR, HOMA-β
K-value by IVGTT
• Plasma concentrations: Total cholesterol (TC), HDL-C-cholesterol (HDL-C),
LDL-C-cholesterol (LDL-C), Triglycerides
Glucose, insulin
Secondary outcome
• Anthropometric:
Weight, height, waist and hip circumference, BIA
• Plasma concentrations:
ASAT, ALAT, gamma-GT, LDH, alkaline phosphatase
fibrinogen, CRP
Background summary
Background:
treatment with phytosphingosine leads to improvement in cholesterol spectrum and insulin resistance in animal models
Objective:
• To examine if dietary Phytosphingosines improve insulin sensitivity in male patients with the metabolic syndrome.
• To examine if dietary Phytosphingosines improve blood cholesterol levels in male patients with metabolic syndrome.
• To examine the safety and possible side effects of dietary Phytosphingosines
Study Design:
Double blind randomized cross-over placebo controlled intervention study
Planned Sample:
10 patients
Drugs and Dosages:
Phytosphingosine, twice a day 0.5 grams for 28 days
Placebo, twice a day for 28 days
Main Parameters:
• Anthropometric: Weight, height, waist and hip circumference, BIA
• Glucose metabolism: HOMA-IR, HOMA-β
K-value by IVGTT
• Plasma concentrations: Total cholesterol (TC), HDL-C-cholesterol (HDL-C),
LDL-C-cholesterol (LDL-C), Triglycerides
Glucose, insulin
ASAT, ALAT, gamma-GT, LDH, alkaline phosphatase
fibrinogen, CRP
Study objective
Phytosphingosine decreases cholesterol levels and improves insulin sensitivity
Study design
Before and after both 4 week interventions
Intervention
- Phytosphingosine, twice a day 0.5 grams for 28 days
- Placebo, twice a day for 28 days
M. Snel
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
+31 (0)71 5264839
m.snel@lumc.nl
M. Snel
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
+31 (0)71 5264839
m.snel@lumc.nl
Inclusion criteria
1. Male volunteers
2. Age > 18 years and < 70 years
3. BMI > 27 kg/m2 and < 40 kg/m2
4. Central obesity (waist circumference >94 centimetres)
5. Fasting serum glucose > 5.6 mmol/L
6. Fasting serum insulin >15 mU/L
7. TG ≥ 1.7 mmol/L or HDL-C ≤ 1.03 mmol/L
Exclusion criteria
1. Any significant chronic disease
2. Renal, hepatic or another endocrine disease
3. Use of medication known to influence lipolysis and/or glucose metabolism
4. Difficulties to insert an intravenous catheter
5. Smoking
6. Recent blood donation (within the last 3 months)
7. Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1242 |
| NTR-old | NTR1287 |
| Other | : P06-131 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |