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ID
Source
Brief title
Health condition
type 2 diabetes
Sponsors and support
Department of Endocrinology
Academic Medical Center, Amsterdam
the Netherlands
Department of Endocrinology
Academic Medical Center, Amsterdam
the Netherlands
Intervention
Outcome measures
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.
Background summary
N/A
Study objective
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.
Study design
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.
Intervention
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.
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
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
Inclusion criteria
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.
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.
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL3086 |
| NTR-old | NTR3234 |
| Other | METC AMC : 2011_104 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |