Standardised dietary challenge study

Completed

• Conditions: Type 2 Diabetes Mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN27707180
• Lead Sponsor: TNO

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28861127

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-01-09
• Study Start: 2017-04-25
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

All participants:
1. Men, aged 30 to 70 years, inclusive, on study day 1
2. Regular Dutch eating habits (3 main meals including bread) as assessed by the health and lifestyle questionnaire
3. Subject needs to be in a healthy condition or diagnosed as T2DM as assessed by
3.1. Medical history evaluation
3.2. Physical examination
3.3. Results of the pre-study blood test of biochemistry and HbA1c
4. Able to participate in the study, willing to give written informed consent and to comply with the study procedures and restrictions including no use of food supplements
5. Appropriate veins for cannula insertion

Healthy volunteers:
Body mass index (BMI): 20.0-25.0 kg/m2

Patients
1. Diagnosed as T2DM evidenced by a documented history and use of prescription oral glucose-lowering drug(s)
2. Body mass index (BMI): 25.1-34.9 kg/m2

Exclusion Criteria

All participants:
1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 1 of this study
2. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
3. Uncontrolled hypertension: systolic blood pressure = 150 mmHg; diastolic blood pressure = 95 mmHg.
4. Having a history of medical or surgical events other than T2DM that may significantly affect the study outcome, including any inflammatory diseases (e.g. arthritis), psychiatric history, or any gastro-intestinal disorder.
5. Use of medication that might interfere with parameters to be measured or with one of the challenge tests
6. For diabetic subjects, fasting glucose < 7mmol/L after stopping oral antidiabetic treatment for 3 weeks
7. For diabetic subjects: use of insulin
8. Smokers
9. Active in competitive sports, active in recreational sports for more than 6 hours/week, physical activity considered by the screening physician to be too intense because it may jeopardize the study objectives (this includes but is not limited to unusual exercise, intermittent training programs, unusual manual labor, etc)
10. Reported unexplained weight loss or gain of > 4 kg in the month prior to the pre-study screening
11. Reported slimming or medically prescribed diet
12. A reported food allergy or sensitivity
13. Not having a general practitioner
14. Not willing to accept information transfer which concerns participation in the study, or information regarding health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
15. Not willing to give permission to have the general practitioner to be notified upon participation in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
On study days, at baseline (fasting) and then 0.5, 1, 2, 4, 6 and 8 hours after challenge test, blood samples are collected to measure markers of glucose metabolism (including, but not restricted to, glucagon, GLP-1, leptin, insulin), metabolic related (including, but not restricted to, adiponectin, GIP, C-peptide, glutathione ratio), immunology (including, but not restricted to, C reactive protein, serum amyloid A, soluble intercellular adhesion molecule, soluble vascular cell adhesion molecule) and metabolites measured by metabolomics technology (including, but not restricted to, endogenous metabolites involved in energy metabolism, urea cycle, glucose metabolism, ketonbodies, lipid metabolism and amino acids).

Secondary Outcome Measures

Name	Time	Method
Gas exchange parameters including oxygen consumption and carbon dioxide production are quantified by the QUARK indirect calorimeter to reflect the energy metabolism in order to establish the metabolic flexibility of subjects when the energy sources are switched between carbohydrate and lipids on the study visits.