An interventional study of Non-intensive intervention and Intensive intervention in Diabetes Mellitus, Type 2, Obesity and PreDiabetes, sponsored by National Council of Scientific and Technical Research, Argentina. Terminated at 1 site in Argentina. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by National Council of Scientific and Technical Research, Argentina · Not applicable, Interventional, and Treatment
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.
The present study has 2 stages, one cross-sectional and the other longitudinal. In the cross-sectional stage, a characterization of a single sampling of 480 people divided into 4 cohorts of 120 people each will be carried out: reference controls, subjects with obesity, with prediabetes and with type 2 diabetes. A clinical history will be made, as long as a 7-day food record and clinical laboratory tests. Anthropometric assessment will be carried out by recording weight, height, waist and hip circumference, determination of waist/hip ratios, as well as taking 4 skinfolds, bicipital, triceps, subscapular and suprailiac, arm and calf measurements and force through a dynamometer. The 480 people will also undergo gut microbiota and microbiome tests from stool samples.
During the longitudinal stage, subjects of each cohort (120 with obesity, 120 with prediabetes and 120 with type 2 diabetes) will be randomly divided into two intervention groups (with 60 subjects each). One group will follow a non-intensive intervention (personalized face-to-face follow-up every 2 months). The other group will follow an intensive intervention (personalized face-to-face follow-up every 3 weeks and a weekly remote group meeting). In both cases, a food plan will be followed based on the recommendations of the nutrition service of the Hospital de Clínicas, Argentina, in accordance with recommendations from the American Diabetes Association (ADA) 2019 guidelines with an emphasis on plant-based diet and whole foods.
Follow-up and nutritional guidance
Groups of 15 subjects from each intervention arm will be led by 3 healthcare professionals. In every case, the group's functions will be:
To accomplish the mentioned tasks, the group leaders will have support from several students from nutrition careers and healthcare professionals.
Influence of physical activity and exercise
A structured physical exercise protocol will be delivered to all subjects. This protocol includes a warm-up, 3 series of 1 minute of eight different strength exercises, with 2 a minute rest. The objective is to accomplish three sessions per week, which can be done in person and supervised by specialists in the Hospital, or online via video call. Subjects will have to record the amount of achieved repetitions in each series of every exercise already done by each session.
The training volume will be adapted according to the subject's capabilities and progress, with the objective of increasing the number of series and reducing resting time between exercises.
Specific follow-up and support proposals for the intensive intervention
In addition to the already mentioned tasks in the follow-up and nutritional guidance's section, for the intensive intervention subjects, group's functions will also be:
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 468 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →National Council of Scientific and Technical Research, Argentina is the lead sponsor of 18 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for control or reference group:
Inclusion Criteria for people with obesity:
Inclusion Criteria for people with prediabetes:
Inclusion Criteria for people with type 2 diabetes:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
People between 30-60 years old, diagnosed with obesity assigned to the non-intensive intervention.
Behavioral: Non-intensive intervention
People between 30-60 years old, diagnosed with obesity assigned to the intensive intervention.
Behavioral: Intensive intervention
People between 30-60 years old, diagnosed with prediabetes assigned to the non-intensive intervention.
Behavioral: Non-intensive intervention
People between 30-60 years old, diagnosed with prediabetes assigned to the intensive intervention.
Behavioral: Intensive intervention
People between 30-60 years old, diagnosed with type 2 diabetes assigned to the non-intensive intervention.
Behavioral: Non-intensive intervention
People between 30-60 years old, diagnosed with type 2 diabetes assigned to the intensive intervention.
Behavioral: Intensive intervention
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
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
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.
Time frame: 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).
Time frame: at 2 years, checked every 6 months
Metabolic syndrome regression
Participants with diagnosis of metabolic syndrome at baseline who no longer meet metabolic syndrome criteria, according to those established by the Joint Interim Statement in 2009 (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;120:1640 -1645.)
Time frame: at 2 years, checked every 6 months
Insulin resistance
Measured by HOMA-IR, HOMA-B or triglyceride: HDL-C ratio.
Time frame: at 2 years
Gut microbiota diversity changes
Increase of diversity in gut microbiota observed in subjects of the intensive intervention compared to subjects of the non-intensive intervention and also compared to their baseline states.
Time frame: at 2 years, checked every 6 months
Plan to share: Yes — all required data in order to reproduce the publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
Ran from May 2022 to primary completion in Jul 2025, 38 months.
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This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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National Council of Scientific and Technical Research, Argentina