LIfestyle MEtabotype Study A

NCT07868601 | Recruiting

• 1 other identifier: 2026-91-BO-ff
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nutritional and Metabolic Diseases; Prediabetes; Type 2 Diabetes

Keywords

Prediabetes; Type 2 Diabetes; Metabolism; Lifestyle; Glycemic response; Eating timing

Outcome Measures

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

  3 and 10 days

Secondary Outcomes (46)

• Body height

  2 weeks

• Body weight

  2 weeks

• Waist and hip circumference

  2 weeks

• Body Mass Index (BMI)

  2 weeks

• Body composition

  2 weeks

Study Arms (3)

Group A (without Prediabetes or Type 2 Diabetes)

HbA1c \<5.7% and fasting plasma glucose \< 100 mg/dl

Group B (Prediabetes)

HbA1c 5.7-6.4%, or fasting plasma glucose 100-125 mg/dL

Group C (Type 2 Diabetes)

HbA1c ≥6.5%, fasting plasma glucose ≥ 126 mg/dl, or existing T2D diagnosis by physician, or T2D diagnosis based on an available result from standardized 75 g oral glucose tolerance test

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Overweight or obesity (BMI 25-40 kg/m²)
• Good knowledge of German

You may not qualify if:

• 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
• Current pregnancy or breastfeeding
• Severe renal, liver or heart disease
• Existing or past hematological malignancies, other malignant tumors, unless successfully treated more than 12 months before study start
• Severe neurological or psychiatric disorders
• Daily alcohol consumption of more than 20 grams or more than 150 grams per week
• Use of illicit or legal drugs one week prior to study start and during study participation
• Known systemic infections
• Type 1 diabetes and rare forms of diabetes
• Diabetes treatment with insulin or sulfonylureas or diabetes medication in the absence of manifest type 2 diabetes
• Unstable thyroid dysfunction
• Blood coagulation disorders or anticoagulation therapy that cannot be interrupted

Sponsors & Collaborators

• German Institute of Human Nutrition: lead
• Freie Universität Berlin, Center for Cognitive Neuroscience Berlin (CCNB): collaborator
• German Center of Diabetes Research (DZD): collaborator

Study Sites (1)

German Institute of Human Nutrition, Dept. Molecular Metabolism and Precision Nutrition and Decision Neuroscience and Nutrition

Potsdam, Potsdam-Rehbrücke, 14558, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, PBMC, serum, plasma, urine, stool, adipose tissue

MeSH Terms

Conditions

Nutritional and Metabolic Diseases; Prediabetic State; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Olga Ramich, Prof. Dr.

  German Institute of Human Nutrition Potsdam-Rehbruecke and the Charité - Universitätsmedizin Berlin

  PRINCIPAL INVESTIGATOR

• Soyoung Park, Prof. Dr.

  German Institute of Human Nutrition Potsdam-Rehbrücke and the Charité - Universitätsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Ramich, Prof. Dr.

CONTACT

+49 33200 882749; olga.ramich@dife.de

Beeke Peters, MSc

CONTACT

+49 33200 882690; beeke.peters@dife.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 9, 2026
• Study Start: October 10, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)