DPP4 Activity, Microvascular Reactivity and Inflammation

NCT03178019 | Completed

• 1 other identifier: 940.029
• Study Type: observational
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

Dipeptidyl peptidase 4 (DPP4) is a serine exopeptidase able to inactivate various oligopeptides involved in inflammation, immunity and vascular function. Our aim was to investigate the associations between constitutive levels of DPP4 activity and inflammatory biomarkers, skin microvascular reactivity, gut peptides, insulin resistance indexes, heart rate and blood pressure variability, and measures of adiposity in subjects with different grades of glucose tolerance.

Conditions

Overweight; Pre Diabetes; Diabetes Mellitus Type 2 Without Complication

Outcome Measures

Primary Outcomes (2)

• Intergroup analysis of the associations between DPP4 activity and skin microvascular reactivity

  Intergroup analysis of the associations between DPP4 activity and skin microvascular reactivity (blood flux and vasomotion evaluated by Laser-Doppler methods) - baseline assessment and at 30 and 60 min after a standardized meal intake (ingested over 3 minutes)

  63 minutes

• Intergroup analysis of the associations between DPP4 activity and markers of inflammation

  Intergroup analysis of the associations between DPP4 activity and markers of inflammation - baseline assessment and at 30 and 60 min after a standardized meal intake (ingested over 3 minutes)

  63 minutes

Secondary Outcomes (2)

• Intergroup analysis of the associations between DPP4 activity and biochemical parameters

  63 minutes

• Intergroup analysis of the associations between DPP4 activity and insulin resistance indexes, heart rate and blood pressure variability, and measures of adiposity

  Baseline evaluation

Study Arms (3)

Euglycemia group

Normoglycemic/normotolerant subjects

Other: Laser-Doppler methods

Prediabetes group

Subjects with prediabetes

Other: Laser-Doppler methods

Diabetes group

Subjects with type 2 diabetes mellitus

Other: Laser-Doppler methods

Interventions

Laser-Doppler methods OTHER

This was a cross-sectional study in which participants were subjected to a screening phase before being eligible to participate in the study. All subjects were submitted to Laser-Doppler methods (assessment of microcirculatory blood flow), bioimpedance analysis (assessment of body composition), venous blood collections (laboratory analysis), and Finometer Pro (assessment of heart rate variability and blood pressure variability).

Also known as: Venous blood collections, Bioimpedance analysis, Finometer Pro

Diabetes group; Euglycemia group; Prediabetes group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Men and women aged between 18 and 50 years, BMI ≥ 25.0 kg/m², with different degrees of glucose tolerance, and living in the state of Rio de Janeiro (Brazil).

You may qualify if:

• BMI ≥ 25.0 kg/m²
• Any degree of glucose tolerance

You may not qualify if:

• BMI \< 25.0 kg/m²
• Uncontrolled chronic diseases, such as arterial hypertension
• Smoking
• Severe alcoholism
• Moderate to severe chronic kidney disease, heart failure, chronic lung disease, and chronic liver disease
• Fasting serum triglycerides \> 400 mg/dl
• Fasting serum cholesterol \> 300 mg/dl
• Pregnancy and breastfeeding
• Women in the climacteric period
• Individuals who undergo bariatric surgery
• Acute disease at the time of sampling
• Initiation of statin or change in its dose within 60 days
• Use of aspirin and/or fluconazole within 10 days prior to the exams

Sponsors & Collaborators

• Rio de Janeiro State University: lead

MeSH Terms

Conditions

Overweight; Glucose Intolerance

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Wellington S Silva Júnior, MD

  State University of Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2017
• First Posted: June 6, 2017
• Study Start: February 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: June 8, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share