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New treatment option for Prediabetes
Official title Precise Eating Time to Improve Glycemic Control and Cardiometabolic Health in Prediabetes and Diabetes
ClinicalTrials.gov ID: NCT07171281
What this study is testing
- What it's testing
- The objective of this study is to investigate the impact of hypocaloric time-restricted eating (TRE) at different day times (early versus late TRE) on glucose metabolism and other cardiometabolic parameters in individuals with overweight and with normal, or impaired glucose metabolism (prediabetes and type 2 diabetes). In addition, the study aims to elucidate the molecular mechanisms underlying these effects.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Overweight or obesity (BMI 25-40 kg/m²)
- Healthy glucose metabolism (fasting glucose \<100 mg/dl and glucose after 2 hours OGTT \<140 mg/dl)
- OR impaired glucose metabolism (fasting glucose 100-125 mg/dl and/or glucose after 2 hours OGTT 140-199 mg/dl and/or HbA1c 5.7-6.4%)
- OR type 2 diabetes (according to existing medical diagnosis or fasting glucose \>126 mg/dl and/or glucose after 2 hours OGTT \>200 mg/dl and/or HbA1c...
- Daily eating window ≥12 hours
You likely can't join if
- Weight changes \> 5% within past 3 months
- Shift work
- Traveling across more than one time zone within one month prior to the study
- Pregnancy and breastfeeding
- Eating disorders, food intolerance/allergy to ingredients in the diet product, vegan diet, practicing time-restricted eating
- Severe chronic illnesses or other conditions that are incompatible with the planned intervention and examination program (e.g. type 1 diabetes...
See the full eligibility criteria
- Overweight or obesity (BMI 25-40 kg/m²)
- Healthy glucose metabolism (fasting glucose \<100 mg/dl and glucose after 2 hours OGTT \<140 mg/dl)
- OR impaired glucose metabolism (fasting glucose 100-125 mg/dl and/or glucose after 2 hours OGTT 140-199 mg/dl and/or HbA1c 5.7-6.4%)
- OR type 2 diabetes (according to existing medical diagnosis or fasting glucose \>126 mg/dl and/or glucose after 2 hours OGTT \>200 mg/dl and/or HbA1c ≥6.5%)
- Daily eating window ≥12 hours
- Weight changes \> 5% within past 3 months
- Shift work
- Traveling across more than one time zone within one month prior to the study
- Pregnancy and breastfeeding
- Eating disorders, food intolerance/allergy to ingredients in the diet product, vegan diet, practicing time-restricted eating
- Severe chronic illnesses or other conditions that are incompatible with the planned intervention and examination program (e.g. type 1 diabetes, recent cardiovascular event, malabsorption, cancer in the last two years...
- Treatment with insulin, sulfonylureas, and GLP-1 receptor agonists, steroid use (oral, cutaneous, or parenteral), regular intake of melatonin, anticoagulation treatment that cannot be paused
- Extreme early and extreme late chronotypes
The study team makes the final eligibility decision.
Where it's taking place
- Nuthetal, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nuthetal, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.