Metabolic Flexibility to Predict Lifestyle Interventions Outcomes

NCT06329349 | Recruiting

• 1 other identifier: EK VP57/0/2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

Weight loss is a cornerstone of diabetes (T2D) management, yet in clinical practice, its delivery is limited by its perceived burdensome nature and variability in response. Personalization of the interventions to increase their success rate is an unmet clinical need. The proposed project MEPHISTO (Whole body and gut microbiome metabolic flexibility to predict lifestyle intervention outcomes) would aim to identify predictive features related to successful weight loss upon sequential exercise and diet intervention in people living with obesity. To this end, the study aims to conduct a clinical trial where the investigators would implement state-of-the-art physiological phenotyping of metabolic flexibility at the whole-body level and at the level of the gut in persons with obesity before and after exercise and diet + exercise intervention to identify predictive signatures of successful weight loss

Conditions

Obesity

Keywords

obesity; metabolic flexibility; metabolomic; exercise; diet

Outcome Measures

Primary Outcomes (2)

• Change in metabolic flexibility (MetFlex (ΔRQ 200-0))

  change in metabolic flexibility measured as ΔRQ (respiratory quotient) during glucose clamp

  18 months

• Change in insulin sensitivity

  change in insulin sensitivity measured as glucose infusion rate (GIR) during glucose clamp

  18 months

Secondary Outcomes (3)

• Glucose tolerance relate to primary outcomes changes

  18 months

• HbA1c relate to primary outcomes changes

  18 months

• Insulin sensitivity relate to primary outcomes changes

  18 months

Other Outcomes (2)

• Microbiome composition relate to weight loss: exploratory outcome

  18 months

• Metabolomic signatures relate to weight loss: exploratory outcome

  18 months

Study Arms (2)

Intervention

EXPERIMENTAL

Exercise intervention

Other: Exercise; Other: Combined Exercise + Diet

Control

NO INTERVENTION

No intervention.

Interventions

Exercise OTHER

12 weeks, 3 times a week of progressive endurance aerobic exercise (150 to 400kcal AEE per session)

Intervention

Combined Exercise + Diet OTHER

12 weeks, 25% caloric reduction, based on PMID: 37069434

Intervention

Eligibility Criteria

• Age: 25 Years - 45 Years
• Gender Eligibility Details: self-represented women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI\>30
• age 25-45 years

You may not qualify if:

• active cancer
• diabetes (medical history, fasting glycemia \>7.6 and/or 2hOGTT glycemia \>11.1)
• uncontrolled endocrine diseases
• corticosteroid therapy
• immune-suppressive therapy
• pregnancy
• breastfeeding

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Ministry of Health, Czech Republic: collaborator
• EXCELES LX22NPO5104, CarDia: collaborator

Study Sites (3)

University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

RECRUITING

Third Medical Faculty,Charles University

Prague, 10084, Czechia

RECRUITING

Faculty of Sports Science

Prague, 16000, Czechia

RECRUITING

Related Publications (1)

• Ludlova M, Koudelkova K, Pallova J, Koudelkova B, Siklova M, Cahova M, Vetrovsky T, Steffl M, Gojda J. Metabolic Flexibility to Predict Lifestyle Interventions Outcomes (MEPHISTO): Protocol for Predictive Validation Study and Randomized Controlled Trial. JMIR Res Protoc. 2025 May 8;14:e67570. doi: 10.2196/67570.

  PMID: 40340957 DERIVED

MeSH Terms

Conditions

Obesity; Motor Activity

Interventions

Exercise; Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jan Gojda

  Charles University, Czech Republic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Gojda, PhD

CONTACT

+420267163031; jan.gojda@lf3.cuni.cz

Jana Potočková

CONTACT

+420267163031; potocko@fnkv.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ass. prof. MD

Model Details: 2:1 randomized cross-over

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 25, 2024
• Study Start: January 2, 2024
• Primary Completion: December 12, 2025
• Study Completion: April 1, 2026
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (3)