Health TrialsbyHealthPanel

LIfestyle MEtabotype Study A

ConditionsNutritional and Metabolic DiseasesPrediabetesType 2 Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-75
SponsorGerman Institute of Human Nutrition

About this trial

Glycemic responses vary significantly among individuals, even when consuming identical foods or meals, but the factors predicting individual glucose response to food intake remain poorly investigated.

The aim of the LIfestyle MEtabotype study (LIME) observational study is to identify lifestyle-related and mechanistic factors which predict individual postprandial glucose fluctuations in individuals with different glycemic status (prediabetes, type 2 diabetes \[T2D\], and absence of prediabetes or T2D). To address this aim, the study will conduct a comprehensive lifestyle characterization and metabolic, molecular and neurocognitive phenotyping during study center visits and a dietary, glucose, sleep and activity monitoring during the observational phase.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Overweight or obesity (BMI 25-40 kg/m²)

Good knowledge of German

Disqualifiers

Weight changes of more than 5% in the last 3 months

Night shift work

Travel across more than one time zone in the last month before and during study participation

Intensive regular physical activity of more than 2 hours per day

Trial population

Adults (40-75 years) with overweight or obesity and with prediabetes or T2D or without prediabetes and T2D

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 3 trial groups
Group A: Group A (without Prediabetes or Type 2 Diabetes)
Group B: Group B (Prediabetes)
Group C: Group C (Type 2 Diabetes)

Trial outcomes

Primary outcomes

1

Glucose incremental Area Under the Curve (iAUC) after a morning test meal

Glucose iAUC \[mg/dL⋅min\] measured using continuous glucose monitoring (CGM) after a standardized morning test meal as an average of two test days within the observation period

Time frame
3 and 10 days

Secondary outcomes

1

Body height

Body height \[m\] measured using a stadiometer or calibrated wall-mounted measuring tape

Time frame
2 weeks
2

Body weight

Body weight \[kg\] measured by scale weight

Time frame
2 weeks
3

Waist and hip circumference

Waist and hip circumference \[cm\] measured using tape

Time frame
2 weeks
4

Body Mass Index (BMI)

BMI \[kg/m2\], calculated as weight/square height

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

German Institute of Human Nutrition

Lead sponsor

Freie Universität Berlin, Center for Cognitive Neuroscience Berlin (CCNB)

Collaborator

German Center of Diabetes Research (DZD)

Collaborator

Source ClinicalTrials.gov
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