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| Name | Class |
|---|---|
| Charite University, Berlin, Germany | OTHER |
| Helmholtz Center Munich | UNKNOWN |
| Hasso Plattner Institute, Potsdam, Germany | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HP/HC - HC/HP | Experimental | Isocaloric 4-week HP/HC intervention followed by a 4-week HC/HP intervention. |
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| HC/HP - HP/HC | Experimental | Isocaloric 4-week HC/HP intervention followed by a 4-week HP/HC intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet with specific macronutrient composition. | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean 24-hour glucose | Mean 24-hour glucose assessed by continuous glucose monitoring (CGM) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of height | Height measured by stadiometer | 4 weeks |
| Measurement of body weight | Body weight measured by body scale | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olga Ramich, PD Dr. | Contact | +4933200882749 | olga.ramich@dife.de | |
| Marina D´Urso | Contact | +4933200882690 | marina.durso@dife.de |
| Name | Affiliation | Role |
|---|---|---|
| Olga Ramich, PD Dr. | German Institute of Human Nutrition | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Olga Ramich | Recruiting | Potsdam | Potsdam-Rehbrücke | 14558 | Germany |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D011236 | Prediabetic State |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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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.
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| Waist and hip circumference / waist to hip ratio | Waist and hip circumference measured by tape measure | 4 weeks |
| Systolic and diastolic blood pressure | Systolic and diastolic blood pressure changes measurement by manometer | 4 weeks |
| Body fat and lean mass | Body fat and lean mass assessed by bioelectrical impendance analysis (BIA) | 4 weeks |
| Energy expenditure and substrate oxidation rates | Energy expenditure and substrate oxidation rates assessed by indirect calorimetry | 4 weeks |
| Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT)) | GGT, AST, ALT etermined in fasting blood samples | 4 weeks |
| Renal values (creatinine, urea, uric acid) | Renal values determined in fasting blood samples | 4 weeks |
| Intra- und inter-day glycemic variability | Indices of intra- and inter-day glycemic variability assessed by continuous glucose monitoring (CGM) | 4 weeks |
| Glucose levels in meal tolerance test (MTT) | Glucose levels in blood samples collected in 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) | Blood levels of metabolic hormones assessed in fasting state and during the MTT | 4 weeks |
| Inflammatory markers and T cell populations analyses | 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 | 4 weeks |
| Satiety and hunger scores | Satiety and hunger scores assessed using Visual Analog Scale (VAS with a scale of 1-100, where higher values correspond to stronger satiety/hunger) | 4 weeks |
| Sleep/wake timing and sleep quality | 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 | 4 weeks |
| Physical activity | 24-h physical activity will be monitored by an ActiGraph device | 4 weeks |
| Adipose tissue transcriptome | RNA-Seq analysis of subcutaneous adipose tissue sample | 4 weeks |
| Gene expression in peripheral blood mononuclear cells (PBMC) | Expression of metabolic genes assessed by qPCR | 4 weeks |
| Gut microbiota and microbiome-derived metabolites | Determined in stool samples and blood plasma | 4 weeks |
| Determination of decision behavior | Impulsiveness assessed by decision making tasks on computer | 4 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |