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Metabolic day-night rhythms in type 2 diabetes.


- candidate number10797
- NTR NumberNTR3234
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-dec-2011
- Secondary IDs2011_104 METC AMC
- Public TitleMetabolic day-night rhythms in type 2 diabetes.
- Scientific TitleCircadian rhythms of glucose metabolism, adipose gene expression and coagulation in type 2 diabetes.
- ACRONYMRHYTHM
- hypothesisType 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) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteriaPatients:
1. Male;
2. Type 2 diabetes;
3. Age 30-75 yr;
4. BMI 25-40 kg/m2.

Age matched controls:
1. Age 30-75 yr;
2. Male;
3. BMI <25 kg/m2.
- Exclusion criteriaPatients:
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.

Controls:
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 receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2012
- planned closingdate1-jun-2013
- Target number of participants12
- InterventionsSubjects 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 outcomeDifference between type 2 diabetes patients and healthy controls in circadian rhythm of postprandial glucose excursions, hemostatic parameters and gene expression in adipose tissue.
- Secondary outcomeDifference between type 2 diabetes patients and healthy controls in circadian rhythms of insulin excursions, free fatty acid responses and oxidative stress.
- TimepointsDuring 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 siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. D.J. Stenvers
- CONTACT for SCIENTIFIC QUERIESDr. P.H.L.T. Bisschop
- Sponsor/Initiator Academic Medical Center (AMC), Department of Endocrinology and Metabolism
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Endocrinology and Metabolism
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD29-dec-2011 - 23-mrt-2013


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