Characterization of the Incretinpathy in Type 2 Diabetes Initiated After Sixty Years Old

This study has been completed.
Sponsor:
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT00843232
First received: February 12, 2009
Last updated: February 3, 2011
Last verified: February 2011
  Purpose

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.


Condition
Diabetes Mellitus, Type 2
Insulin Resistance

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Physiopathology of Type 2 Diabetes Initiated After Sixty Years Old: Characterization of a Diabetic-related Incretinpathy in Aging Subjects.

Resource links provided by NLM:


Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Sera and plasma


Enrollment: 24
Study Start Date: July 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Elderly T2DM
Elderly T2DM subjects 65 to 80 years old
Middle-age T2DM
Middle-age T2DM subjects 35 to 50 years old

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult Type 2 Diabetes subjects

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00843232

Locations
Brazil
LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
Campinas, SP, Brazil
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Principal Investigator: 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)
  More Information

No publications provided

Responsible Party: Bruno Geloneze, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT00843232     History of Changes
Other Study ID Numbers: LIMED0007
Study First Received: February 12, 2009
Last Updated: February 3, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
diabetes mellitus, type 2
Insulin resistance
Aging
Incretins
DPP-IV protein, human
Glucagon-Like Peptide 1
Gastric Inhibitory Polypeptide
insulin
glucagon
ghrelin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Gastric Inhibitory Polypeptide
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014