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…
ID
Bron
Verkorte titel
Aandoening
type 2 diabetes
Ondersteuning
Department of Endocrinology
Academic Medical Center, Amsterdam
the Netherlands
Department of Endocrinology
Academic Medical Center, Amsterdam
the Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Difference between type 2 diabetes patients and healthy controls in circadian rhythm of postprandial glucose excursions, hemostatic parameters and gene expression in adipose tissue.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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.
Publiek
Department of Endocrinology and Metabolism<br>
Academic Medical Center, Amsterdam
D.J. Stenvers
Amsterdam
The Netherlands
+31 (0)20 5663507
d.j.stenvers@amc.uva.nl
Wetenschappelijk
Department of Endocrinology and Metabolism<br>
Academic Medical Center, Amsterdam
D.J. Stenvers
Amsterdam
The Netherlands
+31 (0)20 5663507
d.j.stenvers@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients:
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3086 |
| NTR-old | NTR3234 |
| Ander register | METC AMC : 2011_104 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |