Metabolic effects of morning light in obesity and type 2 diabetes

Completed

Conditions: type 2 diabetes
10018424

Registration Number: NL-OMON38552

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

Group 1 (n<=8):
- age 18-80 years
- male sex
- BMI >25 kg/m2
- habitual wake-up time between 6:00 and 9:00
- no DM2: fasting venous plasma glucose <6.1 mmol/l and HbA1c <6.5%;Group 2 (n<=8):
- age 18-80 years
- male sex
- BMI >25 kg/m2
- habitual wake-up time between 6:00 and 9:00
- type 2 diabetes: fasting venous plasma glucose >6.9 mmol/l or HbA1c > 6.5%

Exclusion Criteria

- use of any other medication than metformin that interferers with glucose metabolism or neuronal synaptic transmission (corticosteroids, anti-depressants, anti-epileptic medication, other psychotropic drugs, anti malarials)
- gastro-intestinal or metabolic disease that will interfere with digestion or metabolism
- neuropsychiatric illness including severe depression
- epilepsy
- hypertension
- ophthalmological abnormalities (e.g. retinopathy)
- lactose intolerance
- soy allergy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Postprandial glucose excursions, and expression of metabolic genes in adipose<br /><br>tissue.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- postprandial insulin excursions<br /><br>- postprandial free fatty acid (FFA) excursions<br /><br>- postprandial triglyceride levels<br /><br>- morning glucocorticoid increase<br /><br>- morning salivary melatonin decrease<br /><br>- resting energy expenditure (REE)<br /><br>- measurements of autonomic balance:<br /><br>- skin temperature decrease<br /><br>- heart rate variability<br /><br>- hunger and satiety ratings<br /><br>- clock gene expression in leucocytes </p><br>