To determine whether different circadian rhythms exist between patients with type 2 diabetes and controls in glucose responses, and whether this difference is best detected by either continuous glucose measurement or venous blood sampling. To…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Glucose metabolism disorders (incl diabetes mellitus)
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference between patients and controls in circadian glucose excursions,
hemostasis, and gene expression profiles in adipose tissue.
Secondary outcome
n/a
Background summary
Type 2 diabetes is a major threat to human health, due to the numerous
microvasvular and macrovascular complications. Previous studies suggest an
altered circadian rhythm of glucose metabolism, leukocyte clock gene expression
and hemostasis in patients with type 2 diabetes. However, glucose metabolism
and hemostasis have never been compared between patients with type 2 diabetes
and controls in a single design. Circadian clock gene expression in adipose
tissue may anticipate circadian changes in food intake, and a disturbance in
this circadian rhythm may be involved in the pathophysiology of type 2
diabetes. However, circadian gene expression in adipose tissue has never been
evaluated in patients with type 2 diabetes.
Study objective
To determine whether different circadian rhythms exist between patients with
type 2 diabetes and controls in glucose responses, and whether this difference
is best detected by either continuous glucose measurement or venous blood
sampling. To determine whether patients with type 2 diabetes show altered
circadian gene expression profiles in adipose tissue.
Study design
Open-label intervention study
Intervention
Subjects will take isocaloric meal replacement by standard liquid meal
replacement (Ensure, Abbott industries) divided into three identical meals at
fixed timepoints.
Study burden and risks
Subjects will record daily food intake for three days followed by a three day
intervention period. During the intervention periods subjects will take three
identical isocaloric meals at fixed timepoints. Patients will wear an actigraph
and a device for continuous glucose measurements. On the first day of each
intervention period a fasting blood sample will be obtained. On the evening of
the second day patients will be admitted to the clinical research unit for 24
hours, for circadian profiles of postprandial glucose excursions and
hemostasis. Four subcutaneous adipose tissue biopsies will be performed to
investigate circadian gene expression. The risks associated with the
nutritional intervention, continous glucose measurement and venous blood
sampling are negligible. Total blood volume sampled will not exceed 220 ml.
Subcutaneous fat biopsies from the periumbilical region will be preceded by
local anesthesia with lidocain, will only cause minor discomfort and have
negligible risks of hemorrhage or infection.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients: Male, type 2 diabetes, Age 30-75 yr, BMI 25-40 kg/m2
Controls: Male, Age 30-75 yr , BMI <25 kg/m2
Exclusion criteria
Patients:
Use of any other anti-diabetic drug than metformin
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
Inability to give informed consent
Shift work in the month before intervention
Crossing several timezones in the month before intervention;Controls
Any acute or chronic metabolic disease that will impair metabolism or digestion and absorption of food, including gastro-intestinal, hepatic or renal disease
Inability to give informed consent
Shift work in the month before intervention
Crossing several timezones in the month before intervention
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 |
|---|---|
| CCMO | NL36145.018.11 |