Physical Exercise, Diet, and Health in People With Type 2 Diabetes: Longitudinal Design of the EDUGUTION Study

NCT06219850 | Unknown

• 1 other identifier: EDUGUTION YEAR
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This longitudinal design study is a continuation of the EDUGUTION project (Ref: PID2019-110063RA-I00; Clinical Trial: NCT05261373), a randomized controlled trial that was approved by the Clinical Research Ethics Committee of Cadiz (Registration No. 92.21; PEIBA No. 1026-N-21) in 2021. The aim of this study was to determine the benefits of three months of intervention with physical exercise and nutritional counseling on health in patients with type 2 diabetes. Specifically, the aim of the present longitudinal study is to analyze the possible changes that may have occurred in the health and lifestyle habits of the subjects of the EDUGUTION project one year after the end of the study. The tests to be performed are the following: 1) Analysis of sociodemographic information, diet and habits and quality of life with previously validated questionnaires, 2) Fasting blood collection, 3) Anthropometric and body composition assessment, 4) Assessment of physical fitness: manual grip strength and maximal oxygen uptake test. On the same day in the morning, participants will have to go to the University Hospital of Puerto Real and to the Exercise Physiology Laboratory of the Faculty of Education Sciences of the Puerto Real Campus of the University of Cadiz, one year after the end of the EDUGUTION study. Since there is no intervention, the duration of the study is a single day. In this study 120 patients will participate, the same patients who were included based on the inclusion and exclusion criteria and who completed the EDUGUTION study intervention one year earlier.

Conditions

Fat Burn; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Metabolism Disorder

Keywords

exercise; diet; metabolism; physical fitness; cardiometabolic risk; gut microbiota

Outcome Measures

Primary Outcomes (7)

• Assessed changes in Plasma Insulin

  The ELISA technique will be used to determine the concentration of plasma insulin (mU/L) in a fasting situation.

  1 year

• Assessed changes in Plasma Glucose

  Plasma glucose (mg/dL) will be analysed in a fasting situation.

  1 year

• Assessed changes in Glycosylated haemoglobin

  Glycosylated haemoglobin (%) will be analysed in a fasting situation with the ADAMS™ A1C HA-8180V.

  1 year

• Assessed changes in Insulin Resistance

  The Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be calculated using the glucose and insulin variables (HOMA-IR = fasting glucose (mg/dL) x fasting insulin (mU/L)/405).

  1 year

• Assessed changes from Body composition: Fatmass and Fat-free mass

  Body composition will be estimated using a multifrequency bioimpedance of 8 electrodes previously validated (TANITAMC780MA). The calculation of impedance can estimate the fat mass and fat-free mass in kilograms. The patients will wear light clothing and will assume a posture in accordance with the manufacturers' instructions. Other previous considerations will be followed 24 hours before the measure: (i) to refrain from vigorous exercise, (ii) to take alcoholic drinks, (iii) to take energy drinks, and (iv) to be in a fasting state for at least 8 hours.

  1 year

• Assessed changes in Muscle Strength

  Muscle strength will be assessed by a manual grip test with a TKK-5401 digital hand-held dynamometer.

  1 year

• Assessed changes from cardiorespiratory fitness

  Cardiorespiratory fitness will be assessed by an incremental test to exhaustion on a cycloergometer using a Jaeger MasterScreen CPX® gas analyzer (CareFusion, San Diego, USA). The test will start with a load of 30W in women and 50W in men, increasing 20W every minute until reaching maximal exhaustion to know the VO2max (maximal oxygen uptake). A pedaling cadence of over 70 rpm should be maintained throughout the test. During the stress test, Dr. Jose Maria Martin Cano (collegiate number: 111108959) will control the heart rate and vital signs to prevent any risk in the test or if there is any emergency situation.

  1 year

Secondary Outcomes (6)

• Assessed changes from Sociodemographic situation

  1 year

• Assessed changes from self-reported quality of life

  1 year

• Assessed changes from Mediterranean diet adherence

  1 year

• Assessed changes in Stool status

  1 year

• Assessed changes in Sleep quality

  1 year

Study Arms (6)

HIIT+Diet

High-Intensity Interval Training (HIIT) and Nutritional education

Other: No intervention

MICT+Diet

Moderate-Intensity Continuous Training (MICT) and Nutritional education

Other: No intervention

HIIT+NoDiet

High-Intensity Interval Training (HIIT) without Nutritional education. The HIIT training consisted of 3 sessions per week in a cycle ergometer, with 1-2 days off between sessions, during a total of 12 weeks under the supervision of a personal trainer. HIIT program consisted of 10 series of 1 min duration at 90% of peak power output, with 60 seconds of rest between sets (estimated total time of the session: 25 minutes).

Other: No intervention

MICT+NoDiet

Moderate-Intensity Continuous Training (MICT) without Nutritional education. The MICT training consisted of 3 sessions per week in a cycle ergometer during 50 min at moderate intensity, with 1-2 days off between sessions, during a total of 12 weeks under the supervision of a personal trainer.

Other: No intervention

Diet+NoExercise

Nutritional education without Exercise. The education intervention consisted of individual nutritional counselling. The nutritional education program was conducted every 2 weeks for 12 consecutive weeks, with 20-min counselling sessions by an experienced nutritionist. Participants were provided with an introduction (in an easy-to-understand manner) regarding the association between T2DM, gut microbiome and dietary habits. Firstly, the diet of the patient should be analysed, to determine which aspects can be improved, such as, total calories intake, amount and types of carbohydrates (highlighting the relevance of fibre), etc. Moreover, some suggestions about the combination of foods and culinary technical in order to manage the glycaemic index of foods were provided.

Other: No intervention

Control group

Neither exercise nor nutritional education

Other: No intervention

Interventions

No intervention OTHER

The study sample is divided into the six intervention groups of the EDUGUTION study (ClinicalTrials.gov Identifier: NCT05261373), although participants do not receive intervention in the present study, as only a description of the sample is made one year after the EDUGUTION study from a longitudinal perspective.

Control group; Diet+NoExercise; HIIT+Diet; HIIT+NoDiet; MICT+Diet; MICT+NoDiet

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The sample of the present study consisted of adults (40-55 years) with type 2 diabetes mellitus or pre-diabetes. Patients must not be insulin dependent and all must be overweight/obese and sedentary people.

You may qualify if:

• Non smoking
• Non-alcoholic (\<3 standard drinks per day)
• Body mass index \>25 kg/m maintaining the habitual dietary patterns without a body mass reduction higher than 2% during the last 6 months
• Not being insulin dependent
• Absence of injury, disease or disability or other known medical condition which could affect the ability to successfully participate in physical exercise tests
• Absence of cardiovascular disease (angina, peripheral or cerebro-vascular disease).
• Absence of neurologic and psychiatric diseases.
• Absence of respiratory diseases (pulmonary hypertension, Chronic obstructive pulmonary disease, etc.).
• Absence of other metabolic diseases (hyper/hypo parathyroidism, hyper/hypothyroidism, Cushing's disease, Type 1 diabetes, etc.)
• Absence of active inflammatory bowel disease
• Absence of kidney disease
• Absence of tumours
• Absence of coagulation dysfunction
• Not under treatment with medications k known to affect glucose metabolism, recent steroid treatment (within 6 months), or hormone replacement therapy
• Be able to understand a communication in Spanish or English.

You may not qualify if:

• Failure to complete the EDUGUTION study measurements and the intervention.

Sponsors & Collaborators

• University of Cadiz: lead
• Ministerio de Ciencia e Innovación, Spain: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be drawn by venous puncture for the measurement of different blood parameters (routine biochemistry, glycosylated hemoglobin, hemogram, hormones and exosomes). A clinical staff will take blood samples from a forearm vein after 8-10 hours of fasting. The sample will be collected in three Vacutainer plasma separator tubes anticoagulated with EDTA or heparin (5ml per tube) and one Vacutainer serum separator tube (10ml). Blood samples will be centrifuged for separation of plasma and serum, which will be stored at -80 °C until analysis.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Metabolic Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: January 23, 2024
• Study Start: February 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: January 1, 2025
• Last Updated: January 23, 2024

Record last verified: 2024-01