adult-onset diabetes obesity overweight Type 2 diabetes mellitus
Conditions
Interventions
During a period of 12 weeks, each group will receive either a diet optimal for
MIR or a diet optimal for LIR with respect to disposition index as determinant
of blood glucose homeostasis.
The opti
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Overweight/obese (BMI >= 25 kg/m2
Exclusion criteria
Exclusion criteria: - Pre-diagnosis of type 1 or type 2 diabetes mellitus - Renal or hepatic malfunctioning (pre-diagnosis or determined based on ALAT, ASAT and creatinine values) - Gastrointestinal diseases or abdominal surgery (allowed i.e.: appendectomy, cholecystectomy) - Food allergies, intolerances and/or dietary restrictions interfering with the study (including special diets, vegetarians and eating disorders) - Cardiovascular diseases (e.g. heart failure) or cancer (e.g. non- invasive skin cancer allowed) - High blood pressure (untreated >160/100 mmHg, drug-regulated >140/90 mmHg) - Diseases affecting glucose and/or lipid metabolism (e.g. pheochromocytoma, Cushing*s syndrome, acromegaly) - Anemia defined as Hb men = 3 months prior to and during study allowed) - Use of statins (stable use >= 3 months prior to and during study allowed) - Use of β-blockers (only for the extensive phenotyping participants) - Chronic corticosteroids treatment (>7 consecutive days of treatment) - Use of antibiotics within 3 months prior to the study - Participation in a regular organized sports activities (>4 hours per week) - Having a restricted dietary pattern interfering with the study diets (e.g. vegan or Atkins diet) - Plans to lose weight - Abuse of alcohol (alcohol consumption >14 units/week) and/or drugs - Not willing to limit alcohol consumption to 7 drinks per week - Regular (including use of e-cigarettes) - Use of strong vitamins or other dietary supplements expected to interfere with the study outcomes - Pregnant or lactating women, or women who are planning to become pregnant - Inability to comply with the study diet - Blood donation within the last 3 months - Participation in possibly interfering studies within the last 3 months - Inability to understand study information and/or communicate with staff - Unwillingness to be randomized or sign informed consent - Unwillingness to save data for 15 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to establish the effect of a metabolically targeted, macronutrient manipulated 12-week dietary intervention on the change in disposition index (composite marker of first phase insulin secretion and insulin sensitivity) between optimal and suboptimal diet after participants follow an optimal or suboptimal diet for their phenotype (MIR or LIR). | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary outcomes, we aim to study the effect of 12-weeks of targeted macronutrient manipulation on change in: 1. Tissue-specific insulin sensitivity, glucose tolerance, 24-hour glucose values 2. Body composition and body fat distirbution 3. Circulating metabolites after a high fat mixed meal under fasting and postprandial (high fat mixed meal) conditions 4. Energy metabolism and substrate oxidation during a hyperinsulinemic-euglycemic clamp (2 steps) 5. Baseline blood lipid spectrum 6. Fecal microbiota composition 7. Oral microbiota composition 8. Targeted metabolomics (baseline and during the clamp) 9. Physical and mental performance and well-being. 10. Blood pressure 11. Gene and protein expression in skeletal muscle and adipose tissue. 12. Advanced glycation end-products (AGE) accumulation 13. Carotid artery reactivity 14. Fasting immune metabolism (PBMCs) 15. Outcomes 1-14 listed above in the optimal versus suboptimal diets within the LIR and MIR groups 16. DNA analysis (buffy coat collection, pre-intervention only) | — |
Countries
Netherlands
Outcome results
None listed