An Integrative Study of the Role of Microbiome, Metabolome, Transcriptome and Chronobiology in the Context of Type 2 Diabetes.

NCT06783218 | Completed

• 1 other identifier: KRONODIABET
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this descriptive clinical study is to investigate daily oscillations in glycaemic control between healthy adults and adults with excess weight and who have early-stage prediabetes or T2D and are not taking medications for glycaemic control. The study also explores how these differences relate to changes in daily patterns in oral microbiome and metabolome, circadian markers, and lifestyle factors such as eating, physical activity, light exposure and appetite. The main questions to answer are:

• Healthy adults with normal weight.
• Adults with excess weight (overweight or obesity) with prediabetes/T2D who are not on diabetes medications. The study will involve both semi-controlled settings (where food intake and physical activity are controlled) and free-living conditions. Participants will:
• Wear devices: Use a continuous glucose monitor and a circadian monitoring device for 14 days.
• Attend clinical visits: Visit the Nutritional Intervention Unit (NIU) 4 times for body composition measurements, sample collection (blood, saliva a faeces) and to answer questionnaires. .
• Participate in a 12.5-hours clinical visit day in the NIU under semi-controlled conditions, with the purpose of collecting blood samples before and after breakfast and saliva samples every 4 hours, covering a full 24-hour cycle.
• Keep track of daily habits: Maintain their usual lifestyle while keeping a food diary and recording appetite related feelings.

Conditions

Prediabetes / Type 2 Diabetes; Obesity and Overweight; Insulin Resistance

Keywords

prediabetes; type 2 diabetes; obesity; microbiome; metabolome; eating behaviour; circadian rhythm; glycaemic control

Outcome Measures

Primary Outcomes (1)

• Percentage coefficient of variation of intra-day glucose levels (%CV)

  Measured by continuous glucose monitoring sensor during semi-controlled conditions in the main clinical investigation day (%)

  Clinical Investigation Day 2 (24-hours)

Secondary Outcomes (54)

• Glycaemic variation

  14 days

• Glycated haemoglobin (HbA1c)

  Screening, Clinical Investigation Day 2

• Fasting serum glucose

  Screening, Clinical Investigation Day 2

• Postprandial serum glucose

  Clinical Investigation Day 2, blood samples taken every 30 min for 2 hours (4 timepoints in total)

• Fasting serum insulin

  Clinical Investigation Day 2

Other Outcomes (18)

• Chronotype as assessed by Morningness-Eveningness Questionnaire (MEQ)

  At screening

• Chronotype as assessed by Munich Chronotype Questionnaire (MCTQ)

  Clinical Investigation Day 2 (V2)

• Subjective appetite sensations

  Clinical Investigation Day 2 (V2) (during 14 hours; immediately before and 1.5 and 3 h after every meal, 15 time points in total) and during 3 non-consecutive days during the field phase (free-living conditions; immediately before and after every meal)

Study Arms (2)

Prediabetes/type 2 diabetes

Individuals with excess weight (overweight or obesity) and drug-naïve prediabetes or type 2 diabetes.

Controls

Invididuals without glycaemic control impairment and normal weight, matched on sex and age with the prediabetes/type 2 diabetes group.

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals from a region in the north of Spain. People registered in the Nutrition Research Centre's own database will be invited. In addition, other recruitment channels will be used, such as flyers, advertisements in local press, medical centres and hospitals, social networks and websites.

You may qualify if:

• Women and men between the ages of 30 and 70.
• Meet any criteria diagnosis of prediabetes or type 2 diabetes according to the American Diabetes Association (ADA), without pharmacological treatment for glycaemic control.
• Excess weight, according to body mass index (BMI) value \> 25 kg/m2.
• Body fat percentage, measured by bioelectrical impedance analysis (BIA), above the normal range, according to age and sex, following the classification from Gallagher D, et al. Am J Clin Nutr. 2000;72(3):694-701.
• Women and men between the ages of 30 and 70.
• No impaired glucose metabolism according to ADA diagnostic criteria
• Normal weight, according to BMI value (18,5 - 24,9 kg/m2)
• Body fat percentage, measured by BIA, within the normal range, according to age and sex, following the classification from Gallagher D, et al. Am J Clin Nutr. 2000;72(3):694-701.

You may not qualify if:

• Chronotype within the categories "extreme evening" (\<34) or "extreme morning" (\>76), according to the Hörne-Orberg Morning-Evening Questionnaire (MEQ) classification.
• Weight changes (± 4.5 kg) during the last 3 months.
• Habitually consuming ≥ 14 units of alcohol/week in women and ≥ 21 units of alcohol/week in men.
• Self-reported use of drugs of abuse in the last 12 months.
• Be an active smoker or have quit smoking within the last 3 months.
• Night or late shift work (finishing later than 11 pm on a permanent basis).
• Recent travel across 2 or more time zones during the last month before the start of the study.
• Show poor cooperation or, in the opinion of the investigator, have difficulty following the study procedures.
• In the case of women, being pregnant or breastfeeding .
• Blood donation in the 3 months prior to the beginning of the study.
• Medical conditions:
• Oral diseases, inflammation or lesions at the time of the study.
• Any clinical condition, including chronic metabolic diseases, systemic intestinal, hepatic or renal diseases, when the research team consider that it may influence the results of the study.
• Severe hyperlipidaemia, severe hypertension or hypothyroidism, untreated or treated for less than 3 months with stable dose.
• Have relevant functional or structural abnormalities of the digestive tract, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory diseases or malabsorption.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• European Union Next Generation: collaborator
• Ministry of Science and Innovation, Spain: collaborator
• Government of Navarra: collaborator
• CIBER de Fisiopatología de la Obesidad y Nutrición (CIBERobn).: collaborator

Study Sites (1)

Center for Nutrition Research. University of Navarra

Pamplona, Navarre, 31008, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma, white cells, saliva, faeces

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2; Obesity; Overweight; Insulin Resistance; Feeding Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Behavior, Animal; Behavior

Study Officials

• Pedro González-Muniesa, PhD

  Center for Nutrition Research. University of Navarra

  PRINCIPAL INVESTIGATOR

• María Jesús Moreno-Aliaga, PhD

  Center for Nutrition Research. University of Navarra

  PRINCIPAL INVESTIGATOR

• Ana Velasco-Andonegui, MSc

  Center for Nutrition Research. University of Navarra

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 20, 2025
• Study Start: March 21, 2024
• Primary Completion: October 15, 2024
• Study Completion: October 28, 2024
• Last Updated: January 20, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)