Diabetes Mellitus, Type 2NCT00843232
Characterization of the Incretinpathy in Type 2 Diabetes Initiated After Sixty Years Old
An observational study of Diabetes Mellitus, Type 2 and Insulin Resistance, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Type 2 diabetes (T2DM) is characterized by hyperglycemia, insulin resistance, absolute or relative insulin deficiency, hyperglucagonemia, increased hepatic glucose production, frequently accelerated gastric emptying and obesity. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Insulin Resistance
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2009to Sep 2010
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Type 2 Diabetes subjects
Who may be able to join
- Stable weight (<5% variation) within the last three months
- Age: 35 to 50 years old for middle-age group, and 65 to 80 y old for elderly group
- Body mass index (BMI): 20 to 29.9kg/m2
- T2DM with diagnosis above 35 years and less than 5 years (Middle-age group)
- T2DM with diagnosis above 65 years and less than 5 years (Elderly group)
- Use of oral antidiabetic drugs (that must at stable dose within the last 3 months)
- Not have participated in any study of intervention with drugs in the last six months.
Who cannot join
- Use of estrogen, progestogen, active antipsychotics and systemic corticosteroids
- Use of DPP-IV inhibitors and incretin mimetics (current or within 1 month before)
- Continuous use of insulin or glitazone
- Hepatic cirrhosis, renal failure or any clinical condition with impaired insulin sensitivity
- Smoking
- Obesity
Show all 10Show fewer
- Uncontrolled systemic or disabling diseases
- T2DM treated by non pharmacological methods
- Patients submitted to bariatric surgery
- Latent autoimmune diabetes of the adult (positive anti-GAD antibodies)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
Campinas, São Paulo
About this study
Official title: Physiopathology of Type 2 Diabetes Initiated After Sixty Years Old: Characterization of a Diabetic-related Incretinpathy in Aging Subjects.
Type 2 diabetes (T2DM) is characterized by hyperglycemia, insulin resistance, absolute or relative insulin deficiency, hyperglucagonemia, increased hepatic glucose production, frequently accelerated gastric emptying and obesity. The known effects of the incretin hormone glucagon-like peptide-1 (GLP-1) on the metabolism are stimulation of insulin secretion, inhibition of glucagon secretion and hepatic glucose production, reduction in gastric emptying and modulation of the appetite. T2DM have disturbances in this system, providing a rationale for therapeutic use of GLP-1 in T2DM. Furthermore, GLP-1 seems to exert trophic effects on the beta-cell.
Dipeptidyl Peptidase IV (DPP-IV) inhibitors represent a new class of oral anti-hyperglycemic agents for the treatment of T2DM. The therapeutic utility of these antihyperglycemic agents rests on their ability of to increase active (intact) levels of incretin peptides, including GLP-1 and GIP.
Read more
Twenty four T2DM volunteers will be evaluated by a meal tolerance test (MTT) for incretin hormone measurements, and by the hyperglycemic clamp followed by an arginine test for assessing the beta-cell function and the acute insulin response. Others parameters as body composition and basic biochemistry will be also evaluated at Laboratory of Investigation on Metabolism and Diabetes - LIMED / State university of Campinas, Brazil.
T2DM in elderly are behaving differently. Elderly patients have no increase in liver production of glucose; when obese, have normal insulin secretion, however, display extreme resistance to its action. In non obese individuals, the concentration of glucose necessary for insulin secretion is increased and the action is standard. These findings suggest therefore that the approach should be differentiated treatment for these individuals.
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance
- Keywords
- diabetes mellitus, type 2, Insulin resistance, Aging, Incretins, DPP-IV protein, human, Glucagon-Like Peptide 1, Gastric Inhibitory Polypeptide, insulin, glucagon, ghrelin
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly T2DM | Elderly T2DM subjects 65 to 80 years old | |
| Middle-age T2DM | Middle-age T2DM subjects 35 to 50 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distinctive curves of glucose, C peptide, insulin, glucagon, GLP-1, GIP and ghrelin during a standardized mixed meal tolerance test, in T2DM subjects after sixty-five years old in comparison with middle-age T2DM subjects
Measured: within 1 month from screening visit
Secondary outcomes (4)
Distinctive whole-body insulin sensitivity, as estimated by hyperglycemic clamp in T2DM subjects after sixty-five years old in comparison with middle-age T2DM subjects.
Measured: within 1 month from screening visit
Distinctive beta-cell function (beta-cell secretion and sensitivity), as measured by hyperglycemic clamp, in T2DM subjects after sixty-five years old in comparison with middle-age T2DM subjects
Measured: within 1 month from screening visit
Distinctive acute insulin response as measured by arginine stimulation test in T2DM subjects after sixty-five years old in comparison with middle-age T2DM subjects.
Measured: within 1 month from screening visit
Distinctive DPP-IV activity as measured by spectrophotometer in T2DM subjects after sixty-five years old in comparison with middle-age T2DM subjects.
Measured: within 1 month from screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Investigators
- Bruno Geloneze, MD, PhD, Principal investigator, LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)José Carlos Pareja, MD, PhD, Principal investigator, LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)Carla Fiori, Nurse, Principal investigator, LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)Marcelo MO Lima, MD, Principal investigator, LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)Ana Carolina Vasques, MSNutr, Principal investigator, LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843232
- Sponsor's protocol ID
- LIMED0007
- Status last verified
- Feb 2011
- First submitted
- 12 Feb 2009
- Last updated
- 4 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Geloneze B, de Oliveira Mda S, Vasques AC, Novaes FS, Pareja JC, Tambascia MA. Impaired incretin secretion and pancreatic dysfunction with older age and diabetes. Metabolism. 2014 Jul;63(7):922-9. doi: 10.1016/j.metabol.2014.04.004. Epub 2014 Apr 12.
PubMed 24854384
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiopathology of Type 2 Diabetes Initiated After Sixty Years Old: Characterization of a Diabetic-related Incretinpathy in Aging Subjects.
- ClinicalTrials.gov ID
- NCT00843232
- Acronym / sponsor ID
- LIMED0007
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance
- Keywords
- diabetes mellitus, type 2, Insulin resistance, Aging, Incretins, DPP-IV protein, human, Glucagon-Like Peptide 1, Gastric Inhibitory Polypeptide, insulin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 13 Feb 2009 (estimated)
- 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.
Type 2 diabetes (T2DM) is characterized by hyperglycemia, insulin resistance, absolute or relative insulin deficiency, hyperglucagonemia, increased hepatic glucose production, frequently accelerated gastric emptying and obesity. The known effects of the incretin hormone glucagon-like peptide-1 (GLP-1) on the metabolism are stimulation of insulin secretion, inhibition of glucagon secretion and hepatic glucose production, reduction in gastric emptying and modulation of the appetite. T2DM have disturbances in this system, providing a rationale for therapeutic use of GLP-1 in T2DM. Furthermore, GLP-1 seems to exert trophic effects on the beta-cell.
Dipeptidyl Peptidase IV (DPP-IV) inhibitors represent a new class of oral anti-hyperglycemic agents for the treatment of T2DM. The therapeutic utility of these antihyperglycemic agents rests on their ability of to increase active (intact) levels of incretin peptides, including GLP-1 and GIP.
Twenty four T2DM volunteers will be evaluated by a meal tolerance test (MTT) for incretin hormone measurements, and by the hyperglycemic clamp followed by an arginine test for assessing the beta-cell function and the acute insulin response. Others parameters as body composition and basic biochemistry will be also evaluated at Laboratory of Investigation on Metabolism and Diabetes - LIMED / State university of Campinas, Brazil.
T2DM in elderly are behaving differently. Elderly patients have no increase in liver production of glucose; when obese, have normal insulin secretion, however, display extreme resistance to its action. In non obese individuals, the concentration of glucose necessary for insulin secretion is increased and the action is standard. These findings suggest therefore that the approach should be differentiated treatment for these individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly T2DM | – | –Elderly T2DM subjects 65 to 80 years old |
| Middle-age T2DM | – | –Middle-age T2DM subjects 35 to 50 years old |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Type 2 Diabetes subjects
Key inclusion criteria (7 listed)
- Stable weight (<5% variation) within the last three months
- Age: 35 to 50 years old for middle-age group, and 65 to 80 y old for elderly group
- Body mass index (BMI): 20 to 29.9kg/m2
- T2DM with diagnosis above 35 years and less than 5 years (Middle-age group)
- T2DM with diagnosis above 65 years and less than 5 years (Elderly group)
Key exclusion criteria (10 listed)
- Use of estrogen, progestogen, active antipsychotics and systemic corticosteroids
- Use of DPP-IV inhibitors and incretin mimetics (current or within 1 month before)
- Continuous use of insulin or glitazone
- Hepatic cirrhosis, renal failure or any clinical condition with impaired insulin sensitivity
- Smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distinctive curves of glucose, C peptide, insulin, glucagon, GLP-1, GIP and ghrelin during a standardized mixed meal tolerance test, in T2DM subjects after sixty-five years old in comparison with middle-age T2DM subjects
Time frame: within 1 month from screening visit
4 secondary outcomes
Distinctive whole-body insulin sensitivity, as estimated by hyperglycemic clamp in T2DM subjects after sixty-five years old in comparison with middle-age T2DM subjects.
Time frame: within 1 month from screening visit
Distinctive beta-cell function (beta-cell secretion and sensitivity), as measured by hyperglycemic clamp, in T2DM subjects after sixty-five years old in comparison with middle-age T2DM subjects
Time frame: within 1 month from screening visit
Distinctive acute insulin response as measured by arginine stimulation test in T2DM subjects after sixty-five years old in comparison with middle-age T2DM subjects.
Time frame: within 1 month from screening visit
Distinctive DPP-IV activity as measured by spectrophotometer in T2DM subjects after sixty-five years old in comparison with middle-age T2DM subjects.
Time frame: within 1 month from screening visit
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 4 Feb 2011.
- Derived from this study: PubMed 24854384Geloneze B, de Oliveira Mda S, Vasques AC, Novaes FS, Pareja JC, Tambascia MA. Impaired incretin secretion and pancreatic dysfunction with older age and diabetes. Metabolism. 2014 Jul;63(7):922-9. doi: 10.1016/j.metabol.2014.04.004. Epub 2014 Apr 12.
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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.
Bruno Geloneze, MD, PhD principal investigator
LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
José Carlos Pareja, MD, PhD principal investigator
LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
Carla Fiori, Nurse principal investigator
LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Insulin Resistance, run by University of Campinas, Brazil at 1 site in Brazil.
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 7 inclusion and 10 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 4 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Distinctive curves of glucose, C peptide, insulin, glucagon, GLP-1, GIP and ghrelin during a standardized mixed meal tolerance test, in T2DM subjects after sixty-five years old in comparison with middle-age T2DM subjects (time frame: within 1 month from screening visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00843232, which also lists 1 linked publication.
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 4 Feb 2011.