|- candidate number||10797|
|- NTR Number||NTR3234|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-dec-2011|
|- Secondary IDs||2011_104 METC AMC|
|- Public Title||Metabolic day-night rhythms in type 2 diabetes.|
|- Scientific Title||Circadian rhythms of glucose metabolism, adipose gene expression and coagulation in type 2 diabetes.|
|- hypothesis||Type 2 diabetes is a major threat to human health. Previous studies suggest an altered circadian rhythm of glucose metabolism, leukocyte clock gene expression and hemostasis in patients with type 2 diabetes, but type 2 diabetes patients have never been compared to healthy controls.
We hypothesize that the circadian rhythms of glucose tolerance, coagulation and adipose tissue gene expression are altered in patients with type 2 diabetes compared to healthy controls.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II)|
|- Inclusion criteria||Patients:|
2. Type 2 diabetes;
3. Age 30-75 yr;
4. BMI 25-40 kg/m2.
Age matched controls:
1. Age 30-75 yr;
3. BMI <25 kg/m2.
|- Exclusion criteria||Patients:|
1. Use of any other anti-diabetic drug than metformin;
2. Acute or chronic metabolic disease (other than type 2 diabetes) that will impair metabolism or digestion and absorption of food, including gastro-intestinal, hepatic or renal disease;
3. Inability to give informed consent;
4. Shift work in the month before intervention;
5. Crossing several timezones in the month before intervention.
1. Any acute or chronic metabolic disease that will impair metabolism or digestion and absorption of food, including gastro-intestinal, hepatic or renal disease;
2. Inability to give informed consent;
3. Shift work in the month before intervention;
4. Crossing several timezones in the month before intervention.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-feb-2012|
|- planned closingdate||1-jun-2013|
|- Target number of participants||12|
|- Interventions||Subjects will replace all oral food intake by three identical meals (Enrich Plus, Abbott industries) at fixed timepoints, during three days. Furthermore they will adhere to a fixed sleep wake schedule.
On the third day patients will be admitted for 24 hours for frequent plasma measurements, holter registration and adipose tissue biopsies.
|- Primary outcome||Difference between type 2 diabetes patients and healthy controls in circadian rhythm of postprandial glucose excursions, hemostatic parameters and gene expression in adipose tissue.|
|- Secondary outcome||Difference between type 2 diabetes patients and healthy controls in circadian rhythms of insulin excursions, free fatty acid responses and oxidative stress.|
|- Timepoints||During three days: Continuous measurements of subcutaneous glucose levels, body temperature, physical activity.
During a 24-hr admission: Frequent plasma measurements of glucose, insulin, FFA. coagulatory factors, oxidative stress. Adipose tissue biopsies at four timepoints over 24 hr, Continous measurement of heart rate variability.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD. D.J. Stenvers|
|- CONTACT for SCIENTIFIC QUERIES||Dr. P.H.L.T. Bisschop|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Endocrinology and Metabolism|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Department of Endocrinology and Metabolism|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||29-dec-2011 - 23-mrt-2013|