Effect of the SCL16A11 Risk Haplotype on Treatments to Prevent Type 2 Diabetes

NCT05990205 | Completed Phase 2 DMC

• 1 other identifier: 2579
• Study Type: interventional
• Target: 437
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized clinical trial is to determine the impact of the risk haplotype on SLC16A11 on early therapeutic responses in treatments to prevent T2D in Mexican mestizos with prediabetes. The main question\[s\] it aims to answer are:

• Evaluate the effect of the risk haplotype on weigth loss \>3%
• Evualuate the differences in lipid profiles and glycemic parameters (fasting glucose, HbA1c). Participants will be randomized into two groups: lifestyle intervention (LSI): hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (\>150 min medium intensity per week), or LSI + MET (750 mg metformin twice a day). Researchers will compare carriers and non carriers of the risk haplotype of SLC16A11 to see if there are diferent treatment responses.

Conditions

PreDiabetes

Keywords

PreDiabetes; Metformin; Precision nutrition; SLC16A11; Mexican Mestizos

Outcome Measures

Primary Outcomes (1)

• Change in weigth loss

  Number of participants in each treatment arm reaching the the goal weight loss \>3%

  12 weeks

Secondary Outcomes (6)

• Change in Total-Cholesterol parameters

  12 weeks

• Change in LDL-Cholesterol parameters

  12 weeks

• Change in ApoB

  12 weeks

• Change in NonHDL-Cholesterol

  12 weeks

• Change in fasting glucose

  12 weeks

Study Arms (2)

Life Style Intervention

ACTIVE COMPARATOR

Hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (\>150 min medium intensity per week)

Behavioral: Life Style Intervention

Life Style Intervention + Metformin

ACTIVE COMPARATOR

Hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (\>150 min medium intensity per week) + (750 mg metformin twice a day).

Drug: Life Style Intervention + Metformin

Interventions

Life Style Intervention + Metformin DRUG

hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (\>150 min medium intensity per week) + Metformin extended release 750mg each 12 hours

Also known as: LSI + MET

Life Style Intervention + Metformin

Life Style Intervention BEHAVIORAL

hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (\>150 min medium intensity per week)

Also known as: LSI

Life Style Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mexican mestizos
• At least one prediabetes criteria according to the American Diabetes Association: fasting glucose between 100-124 mg/dL, Glycosylated hemoglobin (HbA1c) between 5.7-6.4, and 2-hour blood sugar between 140 mg/dl-199 mg/dl after an oral load of 75g of glucose) (1);
• Age ranged between 18-65 years
• Overweight or obesity (BMI between 25.0 - 40 kg/m2).

You may not qualify if:

• Chronic diseases
• Pregnancy
• Chronic use of medications that altered plasma glucose levels.

Sponsors & Collaborators

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

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Metformin; Laser Speckle Contrast Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Carlos A Aguilar Salinas, PhD

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 14, 2023
• Study Start: April 17, 2018
• Primary Completion: December 20, 2023
• Study Completion: March 1, 2024
• Last Updated: May 24, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be made available to the broader scientific community within six months of publication or within 18 months of the conclusion of the funding period if the study remains unpublished.
• Access Criteria: Per International standards, we will require from any investigator or entity requesting the data a data-sharing agreement that provides (1) a commitment to using the data only for research purposes and not to identify any individual participants, (2) a commitment to securing the data using appropriate computer technology, and (3) a commitment to destroying or returning the data after analyses are completed.

Locations

ME (1)