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CompletedNCT03178019DPP4Updated Jun 8, 2017

DPP4 Activity, Microvascular Reactivity and Inflammation

An observational study in Overweight, Pre Diabetes and Diabetes Mellitus Type 2 Without Complication, sponsored by Rio de Janeiro State University. Completed. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-08.

Sponsored by Rio de Janeiro State University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
52
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the detailed description

Dipeptidyl peptidase 4 (DPP4), also known as adenosine deaminase binding protein or cluster of differentiation 26 (CD26), is a serine exopeptidase able to inactivate various oligopeptides composed of proline, hydroxyproline, or alanine as the penultimate residue. In recent years, DPP4 has received attention due to its ability to rapidly inactivate the main incretins secreted by the gastrointestinal tract: glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). As its own name already says, incretins enhance insulin secretion in a glucose-dependent fashion, but also suppress or modulate glucagon secretion. Since it was demonstrated that type 2 diabetes mellitus (T2D) have incretin deficiency and hyperglucagonemia on its physiopathology, gliptins emerged as a new class of drugs for the treatment of this disease, acting through the inhibition of DPP4 and consequently ameliorating these defects.

DPP4 not only inactivate incretins but also a number of cytokines, chemokines, and neuropeptides involved in inflammation, immunity and vascular function. Furthermore, evidence from in vitro and in vivo studies, including clinical ones in T2D, suggested that gliptins' inhibition of DPP4 was associated with reduction of inflammatory biomarkers and also attenuation of endothelial dysfunction and atherogenesis, possibly through regulation of the DPP4 substrates.

There is a paucity of studies that associate the constitutive levels of DPP4 activity (i.e., outside the context of pharmacological inhibition of the enzyme) with markers of inflammation and endothelial function, specially tested on skin microcirculation. We hypothesized that constitutive levels of DPP4 activity might be directly associated to inflammation and inversely correlated with skin blood flux and one or more components of vasomotion (suggesting an association with endothelial disfunction) even in the absence of diabetes. 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.

02

Conditions studied

  • Overweight
  • Pre Diabetes
  • Diabetes Mellitus Type 2 Without Complication
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 52 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Rio de Janeiro State University is the lead sponsor of 62 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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).

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
52 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherLaser-Doppler methods

    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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 63 minutes

  2. 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)

    Time frame: 63 minutes

Secondary outcomes

  1. Intergroup analysis of the associations between DPP4 activity and biochemical parameters

    Intergroup comparisons between the associations of DPP4 activity and Biochemical parameters (including gut peptides) - baseline assessment and at 30 and 60 min after a standardized meal intake (ingested over 3 minutes)

    Time frame: 63 minutes

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

    Intergroup analysis of the associations between DPP4 activity and insulin resistance indexes, heart rate and blood pressure variability (evaluated by Finometer Pro), and measures of adiposity at baseline

    Time frame: Baseline evaluation

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03178019
Lead sponsor
Rio de Janeiro State University
Responsible party
Luiz Guilherme Kraemer-Aguiar, MD (Professor, Rio de Janeiro State University) — Principal investigator
First posted
Jun 6, 2017
Start date
Feb 1, 2014
Primary completion
Dec 1, 2015
Completion
Dec 1, 2016
Last update
Jun 8, 2017

Study contacts

Wellington S Silva Júnior, MD
principal investigator · State University of Rio de Janeiro

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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