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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
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.
Olga Ramich
Potsdam, Potsdam-Rehbrücke, Germany
RECRUITINGMean 24-hour glucose
Mean 24-hour glucose assessed by continuous glucose monitoring (CGM)
Time frame: 4 weeks
Measurement of height
Height measured by stadiometer
Time frame: 4 weeks
Measurement of body weight
Body weight measured by body scale
Time frame: 4 weeks
Waist and hip circumference / waist to hip ratio
Waist and hip circumference measured by tape measure
Time frame: 4 weeks
Systolic and diastolic blood pressure
Systolic and diastolic blood pressure changes measurement by manometer
Time frame: 4 weeks
Body fat and lean mass
Body fat and lean mass assessed by bioelectrical impendance analysis (BIA)
Time frame: 4 weeks
Energy expenditure and substrate oxidation rates
Energy expenditure and substrate oxidation rates assessed by indirect calorimetry
Time frame: 4 weeks
Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT))
GGT, AST, ALT etermined in fasting blood samples
Time frame: 4 weeks
Renal values (creatinine, urea, uric acid)
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Renal values determined in fasting blood samples
Time frame: 4 weeks
Intra- und inter-day glycemic variability
Indices of intra- and inter-day glycemic variability assessed by continuous glucose monitoring (CGM)
Time frame: 4 weeks
Glucose levels in meal tolerance test (MTT)
Glucose levels in blood samples collected in MTT
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 4 weeks
Physical activity
24-h physical activity will be monitored by an ActiGraph device
Time frame: 4 weeks
Adipose tissue transcriptome
RNA-Seq analysis of subcutaneous adipose tissue sample
Time frame: 4 weeks
Gene expression in peripheral blood mononuclear cells (PBMC)
Expression of metabolic genes assessed by qPCR
Time frame: 4 weeks
Gut microbiota and microbiome-derived metabolites
Determined in stool samples and blood plasma
Time frame: 4 weeks
Determination of decision behavior
Impulsiveness assessed by decision making tasks on computer
Time frame: 4 weeks