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Recruiting NCT06382480

PROTeIn-rich Meals to Control Glucose

No phase Interventional Overweight Obesity Prediabetes Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diet with specific macronutrient composition..
Who it may be relevant to
Registry conditions: Overweight, Obesity, Prediabetes, Type 2 Diabetes. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Meal Timing-based Strategies to Improve Glucose Metabolism in Prediabetes and Type 2 Diabetes

Overview

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

  • Other Diet 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.

Primary outcome measures

  • Mean 24-hour glucose [Time frame: 4 weeks]
Secondary outcome measures (12)
  • Measurement of height [Time frame: 4 weeks]
  • Measurement of body weight [Time frame: 4 weeks]
  • Waist and hip circumference / waist to hip ratio [Time frame: 4 weeks]
  • Systolic and diastolic blood pressure [Time frame: 4 weeks]
  • Body fat and lean mass [Time frame: 4 weeks]
  • Energy expenditure and substrate oxidation rates [Time frame: 4 weeks]
  • Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT)) [Time frame: 4 weeks]
  • Renal values (creatinine, urea, uric acid) [Time frame: 4 weeks]
  • Intra- und inter-day glycemic variability [Time frame: 4 weeks]
  • Glucose levels in meal tolerance test (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) [Time frame: 4 weeks]
  • Inflammatory markers and T cell populations analyses [Time frame: 4 weeks]

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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Supportive care

Study locations

Germany · 1 center
  • Olga Ramich — Potsdam

Identifiers

NCT: NCT06382480 · 90/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗