Obesity, Overweight, Prediabetes, Type 2 Diabetes
Conditions
Keywords
Glucose, Overweight, Obesity, Prediabetes, Type 2 Diabetes, Metabolism, Chrononutrition, Macronutrient composition, High-protein, High-carb, Isocaloric diet, Prevention and treatment of type 2 diabetes
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.
Interventions
OTHERDiet with specific macronutrient composition.
The intervention is about an isocaloric diet that differs in terms of distribution of carbohydrates and protein throughout the day. The interventions include a HP-breakfast and a HC-dinner vs. a HC-breakfast and a HP-dinner. 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 10%E protein, 60%E carbs, and 30%E fat.
Sponsors
German Institute of Human Nutrition
Charite University, Berlin, Germany
Helmholtz Zentrum München
Hasso Plattner Institute, Potsdam, Germany
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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 divided by a 4-week wash-out phase.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 * Thyroid dysfunction * Heart attack or stroke * Cancer in the last 2 years * Eating disorders, food intolerance/allergy, addiction disorders, digestive disorders intestinal, liver, cardiovascular diseases * Hereditary or acquired coagulation disorders * Non-interruptible intake of blood thinners (anticoagulants) * Specific diets, intermittent fasting * Pregnancy or breastfeeding * Severe internal or psychiatric disorders or other conditions and drugs therapy that might influence the outcome of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean 24-hour glucose | 4 weeks | Mean 24-hour glucose assessed by continuous glucose monitoring (CGM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of height | 4 weeks | Height measured by stadiometer |
| Measurement of body weight | 4 weeks | Body weight measured by body scale |
| Waist and hip circumference / waist to hip ratio | 4 weeks | Waist and hip circumference measured by tape measure |
| Systolic and diastolic blood pressure | 4 weeks | Systolic and diastolic blood pressure changes measurement by manometer |
| Body fat and lean mass | 4 weeks | Body fat and lean mass assessed by bioelectrical impendance analysis (BIA) |
| Energy expenditure and substrate oxidation rates | 4 weeks | Energy expenditure and substrate oxidation rates assessed by indirect calorimetry |
| Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT)) | 4 weeks | GGT, AST, ALT etermined in fasting blood samples |
| Renal values (creatinine, urea, uric acid) | 4 weeks | Renal values determined in fasting blood samples |
| Intra- und inter-day glycemic variability | 4 weeks | Indices of intra- and inter-day glycemic variability assessed by continuous glucose monitoring (CGM) |
| Glucose levels in meal tolerance test (MTT) | 4 weeks | Glucose levels in blood samples collected in MTT |
| Metabolic hormones (insulin, C-peptide, glucagon, glucagon-like peptite 1(GLP-1), gastric inhibitory polypeptide (GIP), peptide YY (PYY), ghrelin, adiponectin, leptin) | 4 weeks | Blood levels of metabolic hormones assessed in fasting state and during the MTT |
| Inflammatory markers and T cell populations analyses | 4 weeks | Level of the inflammatory markers IL-6, TNFa, MCP-1 and T cell populations in circulation and adipose tissue are assessed through blood analysis and fat biopsy |
| Satiety and hunger scores | 4 weeks | Satiety and hunger scores assessed using Visual Analog Scale (VAS with a scale of 1-100, where higher values correspond to stronger satiety/hunger) |
| Sleep/wake timing and sleep quality | 4 weeks | Sleep/wake timing and sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI score, which ranges from 0-21, where higher values correspond to worse sleep quality) and also monitored by an ActiGraph device |
| Physical activity | 4 weeks | 24-h physical activity will be monitored by an ActiGraph device |
| Adipose tissue transcriptome | 4 weeks | RNA-Seq analysis of subcutaneous adipose tissue sample |
| Gene expression in peripheral blood mononuclear cells (PBMC) | 4 weeks | Expression of metabolic genes assessed by qPCR |
| Gut microbiota and microbiome-derived metabolites | 4 weeks | Determined in stool samples and blood plasma |
| Determination of decision behavior | 4 weeks | Impulsiveness assessed by decision making tasks on computer |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATOROlga Ramich, PD Dr.
German Institute of Human Nutrition
Outcome results
None listed