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Metabolic day-night rhythms in type 2 diabetes.

Circadian rhythms of glucose metabolism, adipose gene expression and coagulation in type 2 diabetes.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26231
Enrollment
12
Registered
2011-12-29
Start date
2012-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes

Interventions

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

Sponsors

P.H.L.T. Bisschop, MD PhD Department of Endocrinology Academic Medical Center, Amsterdam the Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Difference between type 2 diabetes patients and healthy controls in circadian rhythms of insulin excursions, free fatty acid responses and oxidative stress.

Contacts

Public ContactD.J. Stenvers

Room F5-165 Department of Endocrinology and Metabolism Academic Medical Center, Amsterdam

d.j.stenvers@amc.uva.nl+31 (0)20 5663507

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)