Effect of Dietary Protein on the Regulation of Exosome microRNA Expression in Patients With Insulin Resistance.

NCT05318898 | Completed DMC

• 1 other identifier: 3986-22-22-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

miRNAs are small non-coding RNAs of approximately 22 nucleotides in length, which have the function of regulating gene expression at the post-transcriptional level through base complementation of protein-coding transcripts, this interaction leading to translational repression by destabilizing the messenger RNA. Evidence demonstrates an association between differences in miRNA expression and the development of various pathologies, including obesity, type 2 diabetes, cardiovascular disease, neurodegenerative disorders and cancer. Other factors that could also modulate miRNA expression include nutritional status, diet and even exercise. The aim of this study is to identify exosome microRNAs that modify their expression in plasma from patients with insulin resistance fed different dietary protein sources. A randomized controlled clinical trial will be performed where the selected participants will be assigned by lottery to a dietary intervention of usual diet with protein of plant or animal origin for 4 weeks. The study will consist of 3 visits where anthropometric parameters, body composition, systolic and diastolic blood pressure, dietary compliance through 24-hour recall and food logs, biochemical tests (insulin, glucose, triglycerides, total cholesterol, HDL, LDL), the relative expression of plasma exosome miRNAs and markers of oxidative stress will be evaluated. Participants will receive a weekly food pantry during the first two visits in order to improve compliance to the dietary intervention.

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Change in the expression profile of microRNAs from exosomes with real -time quantitative polymerase chain reaction in fold change

  Fold change in the expression profile of microRNAs from exosomes after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal) with real -time quantitative polymerase chain reaction

  4 weeks

Secondary Outcomes (11)

• Change on HOMA index

  4 weeks

• Change in body weight in kg

  4 weeks

• Change in biochemical parameters in mg/dL

  4 weeks

• Change in body composition in percentage

  4 weeks

• Change in C Reactive Protein in mg/L

  4 weeks

Study Arms (2)

Regular diet with vegetable protein

EXPERIMENTAL

Nutritional recommendations will be given to ensure that the patient consumes a regular diet where the protein intake will be mostly from vegetable protein sources.

Other: Vegetal protein

Regular diet with animal protein

ACTIVE COMPARATOR

Nutritional recommendations will be given to ensure that the patient consumes a regular diet where the protein intake will be mostly from animal protein sources.

Other: Animal protein

Interventions

Vegetal protein OTHER

Nutritional recommendations will be given to ensure that the patient consumes a regular diet where the protein intake will be mostly from vegetal protein sources

Regular diet with vegetable protein

Animal protein OTHER

Nutritional recommendations will be given to ensure that the patient consumes a regular diet where the protein intake will be mostly from animal protein sources.

Regular diet with animal protein

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults (men and women) between the ages of 18 and 60.
• Patients with obesity (BMI ≥ 30 and ≤ 50 kg / m2) and with insulin resistance (HOMA - Insulin Resistance Index ≥ 2.5).
• Signature of letter of consent

You may not qualify if:

• Patients with any type of diabetes.
• Patients with kidney disease diagnosed by a medical or with creatinine\> 1.3 mg / dL for men and \> 1.1 mg / dL for women and / or blood urea nitrogen \> 20 mg / dL.
• Patients with acquired diseases that produce obesity and diabetes secondarily.
• Patients who have suffered a cardiovascular event.
• Patients with weight loss \> 3 kg in the last 3 months.
• Patients with any catabolic diseases.
• Gravidity status
• Positive smoking and alcoholism
• Treatment with any medication

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (2)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico City, 14080, Mexico

Location

Martha Guevara Cruz

Mexico City, 14060, Mexico

Location

Related Publications (7)

• Lasser C. Mapping Extracellular RNA Sheds Lights on Distinct Carriers. Cell. 2019 Apr 4;177(2):228-230. doi: 10.1016/j.cell.2019.03.027.

  PMID: 30951666 BACKGROUND

• Mori MA, Ludwig RG, Garcia-Martin R, Brandao BB, Kahn CR. Extracellular miRNAs: From Biomarkers to Mediators of Physiology and Disease. Cell Metab. 2019 Oct 1;30(4):656-673. doi: 10.1016/j.cmet.2019.07.011. Epub 2019 Aug 22.

  PMID: 31447320 BACKGROUND

• Safdar A, Tarnopolsky MA. Exosomes as Mediators of the Systemic Adaptations to Endurance Exercise. Cold Spring Harb Perspect Med. 2018 Mar 1;8(3):a029827. doi: 10.1101/cshperspect.a029827.

  PMID: 28490541 BACKGROUND

• Huang Y, Yan Y, Xv W, Qian G, Li C, Zou H, Li Y. A New Insight into the Roles of MiRNAs in Metabolic Syndrome. Biomed Res Int. 2018 Dec 17;2018:7372636. doi: 10.1155/2018/7372636. eCollection 2018.

  PMID: 30648107 BACKGROUND

• Castano C, Kalko S, Novials A, Parrizas M. Obesity-associated exosomal miRNAs modulate glucose and lipid metabolism in mice. Proc Natl Acad Sci U S A. 2018 Nov 27;115(48):12158-12163. doi: 10.1073/pnas.1808855115. Epub 2018 Nov 14.

  PMID: 30429322 BACKGROUND

• Jimenez-Lucena R, Alcala-Diaz JF, Roncero-Ramos I, Lopez-Moreno J, Camargo A, Gomez-Delgado F, Quintana-Navarro GM, Vals-Delgado C, Rodriguez-Cantalejo F, Luque RM, Delgado-Lista J, Ordovas JM, Perez-Martinez P, Rangel-Zuniga OA, Lopez-Miranda J. MiRNAs profile as biomarkers of nutritional therapy for the prevention of type 2 diabetes mellitus: From the CORDIOPREV study. Clin Nutr. 2021 Mar;40(3):1028-1038. doi: 10.1016/j.clnu.2020.06.035. Epub 2020 Jul 15.

  PMID: 32723508 BACKGROUND

• Min KH, Yang WM, Lee W. Saturated fatty acids-induced miR-424-5p aggravates insulin resistance via targeting insulin receptor in hepatocytes. Biochem Biophys Res Commun. 2018 Sep 10;503(3):1587-1593. doi: 10.1016/j.bbrc.2018.07.084. Epub 2018 Jul 20.

  PMID: 30033101 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Interventions

GDF1 protein, Xenopus

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Martha Guevara-Cruz, Doctor

  Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The person performing the analysis of the study results should be unaware of the assigned intervention so that such knowledge does not influence the results. Therefore, it will be a person outside the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 8, 2022
• Study Start: September 15, 2023
• Primary Completion: March 1, 2024
• Study Completion: September 10, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)