Dietary patterns to manage glucose levels in prediabetes and type 2 diabetes
Meal Timing-based Strategies to Improve Glucose Metabolism in Prediabetes and Type 2 Diabetes
NA · German Institute of Human Nutrition · NCT06382480
This study is testing two different meal plans to see which one helps people with prediabetes and type 2 diabetes better manage their blood sugar levels.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | German Institute of Human Nutrition (other) |
| Locations | 1 site (Potsdam, Potsdam-Rehbrücke) |
| Trial ID | NCT06382480 on ClinicalTrials.gov |
What this trial studies
This pilot project aims to identify effective dietary patterns for the prevention and treatment of type 2 diabetes by comparing the metabolic effects of two different diets with varying distributions of carbohydrates and protein. Overweight individuals with prediabetes and non-insulin treated type 2 diabetes will participate in a cross-over design study, where they will undergo two isocaloric 4-week interventions. One intervention features a high-protein breakfast and a high-carb dinner, while the other has a high-carb breakfast and a high-protein dinner, separated by a 4-week wash-out phase. The study will assess the impact of these dietary patterns on glucose metabolism and inflammatory status.
Who should consider this trial
Good fit: Ideal candidates for this study are overweight individuals with prediabetes or type 2 diabetes who are not on insulin treatment.
Not a fit: Patients with other types of diabetes, those on insulin treatment, or individuals with significant health issues or dietary restrictions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a dietary approach to better manage glucose levels in individuals with prediabetes and type 2 diabetes.
How similar studies have performed: Other studies have explored dietary interventions for diabetes management, showing promising results, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Potsdam, Potsdam-Rehbrücke
- Olga Ramich — Potsdam, Potsdam-Rehbrücke, Germany (RECRUITING)
Study contacts
- Principal investigator: Olga Ramich, PD Dr. — German Institute of Human Nutrition
- Study coordinator: Olga Ramich, PD Dr.
- Email: olga.ramich@dife.de
- Phone: +4933200882749
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Overweight, Obesity, Prediabetes, Type 2 Diabetes, Glucose, Metabolism, Chrononutrition, Macronutrient composition