NCT00843232

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

February 4, 2011

Status Verified

February 1, 2011

Enrollment Period

1.2 years

First QC Date

February 12, 2009

Last Update Submit

February 3, 2011

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Keywords

diabetes mellitus, type 2Insulin resistanceAgingIncretinsDPP-IV protein, humanGlucagon-Like Peptide 1Gastric Inhibitory Polypeptideinsulinglucagonghrelin

Outcome Measures

Primary Outcomes (1)

  • 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

    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.

    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

    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.

    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.

    within 1 month from screening visit

Study Arms (2)

Elderly T2DM

Elderly T2DM subjects 65 to 80 years old

Middle-age T2DM

Middle-age T2DM subjects 35 to 50 years old

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult Type 2 Diabetes subjects

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)

Campinas, São Paulo, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 24854384DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sera and plasma

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Bruno Geloneze, MD, PhD

    LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)

    PRINCIPAL INVESTIGATOR

  • José Carlos Pareja, MD, PhD

    LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)

    PRINCIPAL INVESTIGATOR

  • Carla Fiori, Nurse

    LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)

    PRINCIPAL INVESTIGATOR

  • Marcelo MO Lima, MD

    LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)

    PRINCIPAL INVESTIGATOR

  • Ana Carolina Vasques, MSNutr

    LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

July 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

February 4, 2011

Record last verified: 2011-02

Locations

BR(1)