Cardiometabolic and Mental Health in the RGV

NCT03436875 | Withdrawn

• 1 other identifier: 2017-094-04
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Microvascular insulin resistance has been shown to precede myocyte insulin resistance and impairments in metabolic function. However, there is no convincing data showing the relationship between impaired microvascular flow and impaired metabolic flexibility. Recent evidence exists that impaired microvascular blood flow in Caucasians directly contributes to impaired metabolic flexibility in Caucasians (Diabetes Care), however there is no such evidence in Hispanics. Since there is a large disparity in cardiometabolic disease in Hispanics, this study aims to determine the role of impaired microvascular blood flow on impaired substrate oxidation switching (metabolic flexibility) in healthy people at risk for developing type 2 diabetes.

Conditions

Microvessels; Carbohydrate Metabolism; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Microvascular responses in skeletal muscle

  Changes in microvascular blood flow in skeletal muscle from fasting to post-OGTT or post-MMC.

  4 years

• Microbiota

  Classification of microbiota to determine its impact on cardiometabolic and mental health

  4 years

Study Arms (2)

Healthy

Healthy people either with (FH+) or without (FH-) a family history of diabetes or Alzheimer's Disease.

unhealthy

People type 2 diabetes or Alzheimer's Disease that have either: a family history of that disease (FH+) or no family history of T2D or Alzheimer's for two generations (FH-).

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Hispanics residing in Southeast Texas ages 18 - 70 years old that have either a parent with type 2 diabetes or Alzheimer's, or no history of type 2 diabetes or Alzeimer's for two generations. People with type 2 diabetes or Alzheimer's and controlled hypertension that have either: a parent with type 2 diabetes, or no history of type 2 diabetes for two generations.

You may qualify if:

• Healthy people, those with T2D, or those with Alzheimer's Disease.
• years
• having either a parent with type 2 diabetes or Alzheimer's, or no history for 2 generations
• non-smoking, weight-stable

You may not qualify if:

• presence of microvascular disease
• smoking
• having gained or lost more than 5lbs in the last 3 months
• pregnancy
• having cancer, liver, or kidney disease within 5 years

Sponsors & Collaborators

• University of Texas Rio Grande Valley: lead

Study Sites (1)

University of Texas Rio Grande Valley - Cardiometabolic Exercise Lab

Brownsville, Texas, 78520, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected during an oral glucose tolerance test. Plasma will be stored in -80 for later testing (insulin, cytokines, etc). Buffy coat will also be stored at -80 for specific SNP analysis for likely candidate genes affecting microvascular blood flow and impaired substrate oxidation. Stool samples will be collected to asses the microbiota.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 19, 2018
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)