Microbiome and Health Indicators in People With Obesity, Prediabetes and Type 2 Diabetes Undergoing a Lifestyle Intervention

NCT05372445 | Terminated

• 1 other identifier: MicrobiAr
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of type 2 diabetes worldwide is growing rapidly, being one of the fastest growing global health emergencies of the 21st century according to the International Diabetes Federation. In MicrobiAr the investigators seek to achieve type 2 diabetes remission through a plant-based diet and lifestyle intervention identifying and characterizing key changes on the gut microbiome during clinical transitions. Specifically, the investigators aim to characterize and follow-up metabolic pathways from gut microbiome and how they evolve as long as health indicators do over the 2 years of this study.

Conditions

Diabetes Mellitus, Type 2; Obesity; PreDiabetes

Keywords

microbiota; microbiome; plant-based diet; type 2 diabetes remission; metabolic syndrome; caloric restriction; metabolic pathways

Outcome Measures

Primary Outcomes (2)

• Clinical improvements in people with type 2 diabetes, prediabetes, or obesity

  These clinical improvements will be defined as: 1. In the group of subjects with type 2 diabetes, remission to non-diabetic stage. Considering remission as measuring HbA1c values lower than 6,5% at least 6 months after beginning the lifestyle intervention and 3 months after cessation of any pharmacotherapy, according to the "Consensus Report: Definition and Interpretation of Remission in Type 2 Diabetes", Diabetes Care 2021;44(10):2438-2444. 2. In the group of subjects with prediabetes, remission to normal glycemia / HbA1c values. Considering normal glycemia lower than 100 mg/gl and HbA1c lower than 5.7%. 3. In the group of overweight-obese subjects, a 10% decrease in weight compared to baseline weight, maintained during the second year of follow-up. Any of the three possible situations will be considered as a clinical improvement event.

  at 2 years, checked every 6 months

• Gut microbiota metabolic pathways changes

  Increase in the number of gut microbiota metabolic pathways possibly expressed in subjects of intensive intervention compared to their baseline states and also compared to subjects of the non-intensive intervention. This metric refers to possibly expressed metabolic pathways predicted from shotgun metagenomics analysis related to regulation of inflammatory processes, carcinogenesis, intestinal barrier function, oxidative stress, production of SCFAs, regulation of immune response and inflammation, production of derivative aromatic amino acids, regulation of bile acids (synthesis of derivative metabolites of cholesterol), regulation of the level of phospholipid synthesis (anaerobic metabolism of choline).

  at 2 years, checked every 6 months

Secondary Outcomes (3)

• Metabolic syndrome regression

  at 2 years, checked every 6 months

• Insulin resistance

  at 2 years

• Gut microbiota diversity changes

  at 2 years, checked every 6 months

Study Arms (7)

Reference Group

NO INTERVENTION

People between 30-60 years old, without obesity, prediabetes or type 2 diabetes. The purpose of this group is to characterize gut microbiota and microbiome to set the reference values of the argentinian local population.

Obesity Group A

ACTIVE COMPARATOR

People between 30-60 years old, diagnosed with obesity assigned to the non-intensive intervention.

Behavioral: Non-intensive intervention

Obesity Group B

EXPERIMENTAL

People between 30-60 years old, diagnosed with obesity assigned to the intensive intervention.

Behavioral: Intensive intervention

Prediabetes Group A

ACTIVE COMPARATOR

People between 30-60 years old, diagnosed with prediabetes assigned to the non-intensive intervention.

Behavioral: Non-intensive intervention

Prediabetes Group B

EXPERIMENTAL

People between 30-60 years old, diagnosed with prediabetes assigned to the intensive intervention.

Behavioral: Intensive intervention

Type 2 Diabetes Group A

ACTIVE COMPARATOR

People between 30-60 years old, diagnosed with type 2 diabetes assigned to the non-intensive intervention.

Behavioral: Non-intensive intervention

Type 2 Diabetes Group B

EXPERIMENTAL

People between 30-60 years old, diagnosed with type 2 diabetes assigned to the intensive intervention.

Behavioral: Intensive intervention

Interventions

Non-intensive intervention BEHAVIORAL

After an evaluation of 7 day initial food-recall, subjects will receive counseling in order to improve their dietary habits, according to the American Diabetes Association 2019 Guidelines. The goals of this intervention are (i) achieve a caloric restriction of 500 kcal from their habitual energy intake, (ii) prioritize natural, minimally processed foods with a low glycemic index and glycemic load, (iii) eat lean protein sources, both from plant and animal origin and (iv) gradual increments of fiber intake, to achieve at least the minimum recommendations for the general population. The frequency of the follow-up appointments will be every 4 weeks, alternating between a clinical control and nutritional one. Therefore, the planned nutritional follow-up frequency will be every 2 months. In these appointments, the objective will be to achieve the mentioned energy intake reduction of 500 kcal, aiming to the nutritional goals previously mentioned, with the aid of the food-recalls.

Also known as: Group A

Obesity Group A; Prediabetes Group A; Type 2 Diabetes Group A

Intensive intervention BEHAVIORAL

People will have virtual education with food and nutrition coaching workshops, as well as weekly meetings in small groups as a support and follow-up groups. The frequency of the face-to-face follow-up appointments will be every 3 weeks. The nutritional intervention will emphasize the consumption of mainly minimally processed food from plant origin. A vitamin b12 supplement per week will be provided. This intervention group will have 2 stages. First stage will have a duration of 3 months setting the nutritional bases going to a plant-based diet with basic considerations regarding fiber intake reducing meat consumption, and incorporating protein from vegetable sources, among other considerations. Second stage will progress to higher levels of fiber and others nutritional requeriments in order to intensify the nutritional plant-based intervention.

Also known as: Group B

Obesity Group B; Prediabetes Group B; Type 2 Diabetes Group B

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects without type 2 diabetes, obesity, prediabetes (glucose intolerance), or metabolic syndrome
• HbA1c less than 42mmol/mol (\<5.7%)
• BMI between 18.5 and 24.9
• BMI greater than 30
• Fasting glucose between 110 and 125 mg/dl
• HbA1c between 42 and 47 mmol/mol (5.7% to 6.4%)
• BMI greater than 30
• Fasting glucose \> 126 mg/dl
• HbA1c \> 48mmol/mol (6.5% or higher)
• BMI greater than 30
• Treatment with metformin at therapeutic dose (1500-2000 mg/day) or maximum tolerated dose.

You may not qualify if:

• Subjects with obesity, pre-diabetes medicated with metformin or another drug for diabetes or obesity
• Subjects with type 2 diabetes medicated with another drug that is not metformin
• Subjects with type 2 diabetes diagnosed over 6 years
• Subjects with type 2 diabetes requiring insulin
• Chronic kidney disease grade greater than 3 (measured by EPI)
• Subjects with type 1 diabetes
• Intestinal diseases, Crohn's, ulcerative colitis, celiac disease
• Use of antibiotics in the last 3 months
• Pregnancy, lactation
• Psychiatric disorders
• Eating disorder
• Gastric bypass surgery
• Transplanted people
• Oncological pathology diagnosed less than 5 years
• Subjects who do not wish to sign the informed consent

Sponsors & Collaborators

• National Council of Scientific and Technical Research, Argentina: lead
• Facultad de Ingeniería - Universidad Austral: collaborator
• Instituto de Inmunología, Genética y Metabolismo (INIGEM, CONICET-UBA): collaborator
• Illumina, Inc.: collaborator
• Zymo Research: collaborator
• Instituto de Investigación y Desarrollo en Bioingeniería y Bioinformática (IBB, CONICET-UNER): collaborator

Study Sites (1)

Hospital de Clínicas "José de San Martín"

Capital Federal, Buenos Aires, C1120AAR, Argentina

Location

Related Publications (2)

• Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.

  PMID: 19805654 BACKGROUND

• Riddle MC, Cefalu WT, Evans PH, Gerstein HC, Nauck MA, Oh WK, Rothberg AE, le Roux CW, Rubino F, Schauer P, Taylor R, Twenefour D. Consensus Report: Definition and Interpretation of Remission in Type 2 Diabetes. Diabetes Care. 2021 Aug 30;44(10):2438-44. doi: 10.2337/dci21-0034. Online ahead of print.

  PMID: 34462270 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Prediabetic State; Metabolic Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Juan Bustamante, PhD

  CONICET Researcher

  PRINCIPAL INVESTIGATOR

• Gustavo Frechtel, PhD

  CONICET Researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bioinformatician, PhD in Biological Chemistry

Study Record Dates

• First Submitted: May 8, 2022
• First Posted: May 12, 2022
• Study Start: May 30, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting immediately after publication in a peer reviewed journal
• Access Criteria: all required data in order to reproduce the publication will be full available in our website www.microbiar.com through a specific section that will be implemented for this aim.

Locations

AR (1)