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Metabolic effects of morning light in obesity and type 2 diabetes


- candidate number18109
- NTR NumberNTR4645
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jun-2014
- Secondary IDs2013_259 METC AMC 
- Public TitleMetabolic effects of morning light in obesity and type 2 diabetes
- Scientific TitleMetabolic effects of morning light in obesity and type 2 diabetes
- ACRONYMSUNRISE 2
- hypothesisType 2 diabetes is a major threat to human health. Disruption of the circadian timing system is associated with metabolic changes. Disturbance of the daily light and dark rhythm could contribute to this phenomenon and effects metabolic pathways. We hypothesize that mornig bright light exposure decreases postprandial glucose excursion in obese subjects with and without type 2 diabetes.
- Healt Condition(s) or Problem(s) studiedGlucose metabolism , Obesity, Diabetes Mellitus Type 2 (DM type II)
- Inclusion criteriaGroup 1
1. Age 18-80 years;
2. Male sex;
3. BMI >25 kg/m2
4. No DM2: Fasting plasma glucose <6.1 mmol/L;
5. Habitual wake-up time between 6:00 and 9:00.

Group2
1. Age 18-80 years;
2. Male sex;
3. BMI >25 kg/m2
4. DM2: Fasting plasma glucose >6.9 mmol/L;
5. Habitual wake-up time between 6:00 and 9:00.
- Exclusion criteria1. Medication interfering with glucose metabolism or neuronal synaptic transmission;
2. Gastro-intestinal or metabolic disease that will interfere with digestion or metabolism;
3. Neuropsychiatric illness including severe depression;
4. Epilepsy;
5. Hypertension;
6. Ophthalmological abnormalities.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2014
- planned closingdate1-dec-2015
- Target number of participants8
- InterventionsSubject will be admitted in the evening and receive a standard meal in normal room light. They sleep for 8 hours in the dark. From wake-up time they consume a standard liquid in bright or dim light.
- Primary outcomeTo investigate the effect of morning light exposure on postprandial glucose excursions and expression of metabolic and clock genes in adipose tissue.
- Secondary outcomeTo investigate the effect of morning light exposure on postprandial insulin excursions, postprandial free fatty acid (FFA) excursions, postprandial triglyceride levels, morning glucocorticoid increase, morning salivary melatonin decrease and measurements of skin temperature decrease and heart rate variability.
- TimepointsFrequent plasma measurements of glucose, insulin, C-peptide, free fatty acid and triglyceride. Adipose tissue biopsy at one timepoint. Continous measurement of heart rate variability and skin temperature.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. D.J. Stenvers
- CONTACT for SCIENTIFIC QUERIESDr. P.H.L.T. Bisschop
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)11-apr-2015: wijziging inclusie:

Old:
Group 1
1. Age 18-80 years;
2. Male sex;
3. BMI >25 kg/m2
4. No DM2: Fasting plasma glucose <6.1 mmol/L;
5. Habitual wake-up time between 6:00 and 9:00.

Group2
1. Age 18-80 years;
2. Male sex;
3. BMI >25 kg/m2
4. DM2: Fasting plasma glucose >6.9 mmol/L;
5. Habitual wake-up time between 6:00 and 9:00.

New:
Group2
1. Age 18-80 years;
2. Male sex;
3. BMI >25 kg/m2
4. DM2: Fasting plasma glucose >6.9 mmol/L;
5. Habitual wake-up time between 6:00 and 9:00.
- RECORD13-jun-2014 - 11-apr-2015


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