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Standardized dietary challenges in healthy and diabetic subjects

Standardized dietary challenges in healthy and diabetic subjects - Standardized dietary challenge study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37022
Enrollment
40
Registered
2012-08-23
Start date
2012-09-11
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

diabetes and healthy subjects

Interventions

Two dietary challenge tests will be applied: an oral lipid tolerance test (OLTT) and an oral glucose tolerance test (OGTT). The OLTT is a drink of about 500 mL which consists of a mixture of 75g glu

Sponsors

TNO
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Males, aged 30 to 55 years. 20 healthy volunteers are defined based on 1) Medical history evaluation; 2) Physical examination; 3) results of the prestudy laboratory tests; 4) Body mass index (BMI): 20-25 kg/m2. 20 Type 2 Diabetes, BMI: 25.1-30 kg/m2, willing to stop antidiabetic medication.

Exclusion criteria

Exclusion criteria: 1)Uncontrolled bloodpresseure: systolic blood pressure >= 150 mmHg; diastolic blood pressure >= 95mmHg. 2)Use of medication that might interfere with parameters to be measured with one of the challenge tests, with the exception of oral antidiabetic drugs. ( use beta blockers, statins, antidiabetic drugs during the study). 3)Smoking 4)physical activity (more than 6 hours per week) 5)unexplained weight loss or gain of > 4 kg in the month prior to the screening 6)followed slimming or medically prescribed diet 7) food allergy or sensitivity 8) For diabetic subjects, fasting glucose

Design outcomes

Primary

MeasureTime frame
glucagon, GLP-1, leptin, insulin, adiponectin, GIP, C-peptide, glutathione ratio, C reactive protein, SAA, sICAM, sVCAM and metabolites. Oxygen consumption and carbon dioxide production.

Secondary

MeasureTime frame
free fatty acids, immunological parameters (IL-1b, IL-6, IL-8, IL-18, TNFa, MCP-1, E-selectin, P-selectin, PAI1, IL1Ra, CXCL9, CXCL10) and others (leptin, cortisol, , PYY, LPS, CK18, nitrite/nitrate ratio).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)