Meal Timing-based Strategies to Improve Glucose Metabolism in Prediabetes and Type 2 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overweight
- Sponsor
- German Institute of Human Nutrition
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Mean 24-hour glucose
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
The overall aim is to identify the dietary pattern for prevention and treatment of type 2 diabetes. The specific aim of this pilot project is to compare effects of two diets with different diurnal distribution of carbohydrates and protein on the glucose metabolism in subjects with prediabetes and type 2 diabetes and its effects on inflammatory status.
Detailed Description
Overweight individual with prediabetes and non-insulin treated type 2 diabetes will be recruited for the study. The trial will have a cross-over design and compare metabolic effects of two isocaloric 4-week interventions with opposite timely distribution of macronutrient intake - a high-protein (HP) breakfast and a high-carb (HC) dinner (HP/HC intervention) vs. a HC breakfast and a HP dinner (HC/HP intervention) - divided by a 4-week wash-out phase. A HP low-carb meal (breakfast or dinner) will contain 35%E protein, 35%E carbs, and 30%E fat, and a HC meal (breakfast or dinner) will contain 10E%protein, 60%E carbs, and 30%E fat.
Investigators
Olga Ramich (formerly Pivovarova)
Head of Research Group Molecular Nutritional Medicine
German Institute of Human Nutrition
Eligibility Criteria
Inclusion Criteria
- •Prediabetes (fasting blood sugar 100-125 mg/dl)
- •Diabetes type 2 (fasting blood sugar \>126 mg/dl)
- •Overweight and obesity (BMI 25-50 kg/m2)
Exclusion Criteria
- •Other diabetes types
- •Insulin treatment
- •Shift work
- •Weight changes \>5% within past 3 months
- •Systemic glucocorticoid therapy
- •Systemic infections
- •Severe anemia
- •High blood pressure (\>180/110 mmHg)
- •Endocrinologic, liver and heart disorders
- •Immune diseases
Outcomes
Primary Outcomes
Mean 24-hour glucose
Time Frame: 4 weeks
Mean 24-hour glucose assessed by continuous glucose monitoring (CGM)
Secondary Outcomes
- Measurement of body weight(4 weeks)
- Renal values (creatinine, urea, uric acid)(4 weeks)
- Intra- und inter-day glycemic variability(4 weeks)
- Inflammatory markers and T cell populations analyses(4 weeks)
- Waist and hip circumference / waist to hip ratio(4 weeks)
- Systolic and diastolic blood pressure(4 weeks)
- Energy expenditure and substrate oxidation rates(4 weeks)
- Measurement of height(4 weeks)
- Body fat and lean mass(4 weeks)
- Gene expression in peripheral blood mononuclear cells (PBMC)(4 weeks)
- Glucose levels in meal tolerance test (MTT)(4 weeks)
- Metabolic hormones (insulin, C-peptide, glucagon, glucagon-like peptite 1(GLP-1), gastric inhibitory polypeptide (GIP), peptide YY (PYY), ghrelin, adiponectin, leptin)(4 weeks)
- Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT))(4 weeks)
- Physical activity(4 weeks)
- Adipose tissue transcriptome(4 weeks)
- Satiety and hunger scores(4 weeks)
- Sleep/wake timing and sleep quality(4 weeks)
- Gut microbiota and microbiome-derived metabolites(4 weeks)
- Determination of decision behavior(4 weeks)