OverweightDPP4NCT03178019
DPP4 Activity, Microvascular Reactivity and Inflammation
An observational study of Overweight and Pre Diabetes, run by Rio de Janeiro State University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Pre Diabetes, Diabetes Mellitus Type 2 Without Complication
- What is being tested?
- Laser-Doppler methods
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2014to 1 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- BMI ≥ 25.0 kg/m²
- Any degree of glucose tolerance
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
Official title: Dipeptidyl Peptidase 4 (DPP4) Activity and Its Associations With Endothelial Dysfunction, Inflammatory and Metabolic Markers, Heart Rate and Blood Pressure Variability, and Measures of Adiposity in Subjects With Different Grades of Glucose Tolerance
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.
- Being tested
- Laser-Doppler methods
- Medical subject headings
- Overweight, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser-Doppler methodsOther
Also called Venous blood collections, Bioimpedance analysis, Finometer Pro
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).
| Study group | Role | What they receive |
|---|---|---|
| Euglycemia group | Normoglycemic/normotolerant subjects Receives: Other: Laser-Doppler methods | |
| Prediabetes group | Subjects with prediabetes Receives: Other: Laser-Doppler methods | |
| Diabetes group | Subjects with type 2 diabetes mellitus Receives: Other: Laser-Doppler methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 63 minutes
Secondary outcomes (2)
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)
Measured: 63 minutes
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
Measured: Baseline evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start1 Feb 2014
- Primary completion1 Dec 2015
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Guilherme Kraemer-Aguiar, MD, Rio de Janeiro State University
- Investigators
- Wellington S Silva Júnior, MD, Principal investigator, State University of Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178019
- Sponsor's protocol ID
- 940.029
- Acronym
- DPP4
- Status last verified
- Jun 2017
- First submitted
- 3 Jun 2017
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dipeptidyl Peptidase 4 (DPP4) Activity and Its Associations With Endothelial Dysfunction, Inflammatory and Metabolic Markers, Heart Rate and Blood Pressure Variability, and Measures of Adiposity in Subjects With Different Grades of Glucose Tolerance
- ClinicalTrials.gov ID
- NCT03178019
- Acronym / sponsor ID
- DPP4 / 940.029
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Euglycemia group | – | Other: Laser-Doppler methodsNormoglycemic/normotolerant subjects |
| Prediabetes group | – | Other: Laser-Doppler methodsSubjects with prediabetes |
| Diabetes group | – | Other: Laser-Doppler methodsSubjects with type 2 diabetes mellitus |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (2 listed)
- BMI ≥ 25.0 kg/m²
- Any degree of glucose tolerance
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser-Doppler methodsAlso: Venous blood collections, Bioimpedance analysis, Finometer ProThis 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). | Other | Diabetes group, Euglycemia group, Prediabetes group |
Primary outcome
Intergroup analysis of the associations between DPP4 activity and skin microvascular reactivity
Time frame: 63 minutes
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)
Intergroup analysis of the associations between DPP4 activity and markers of inflammation
Time frame: 63 minutes
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)
2 secondary outcomes
Intergroup analysis of the associations between DPP4 activity and biochemical parameters
Time frame: 63 minutes
Intergroup analysis of the associations between DPP4 activity and insulin resistance indexes, heart rate and blood pressure variability, and measures of adiposity
Time frame: Baseline evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wellington S Silva Júnior, MD principal investigator
State University of Rio de Janeiro
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Pre Diabetes, run by Rio de Janeiro State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intergroup analysis of the associations between DPP4 activity and skin microvascular reactivity (time frame: 63 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2017.