"Effect of Dipeptidyl Peptidase IV After Diets in näive Type 2 Diabetic Patients"

NCT00881543 | Completed

• 1 other identifier: USaoPauloGH
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate the secretion of glucose, insulin, glucagon, C-peptide and lipid profile after isocaloric diets with different nutritional compounds (fat, protein and carbohydrate food) in drug näive tipo 2 patients.

Conditions

Diabetes Type 2

Keywords

Sitagliptin; Diets; Diabetes type 2; Näive patients

Outcome Measures

Primary Outcomes (1)

• secretion of glucose, insulin, glucagon, C-peptide and lipid profile after isocaloric diets

  One month

Secondary Outcomes (1)

• Washout of dipeptidyl peptidase IV inhibitors after one month without the drug

  One month

Study Arms (2)

1

PLACEBO COMPARATOR

This arm will begin taking the placebo by a month, after a month will be tested the diets (the same caloric amount with different composition on fat, protein and carbohydrates)making curves of insulin, glucagon, C peptide and glp 1 and lipid when diets are tested (three acute tests with diets). After that, the patient will begin the drug by month (Januvia, 100 mg a day)and repeat all the three curves using the prepared diets to compare with the first month.

Drug: Dipeptidyl Peptidase IV inhibitors

2

ACTIVE COMPARATOR

Since the beginning they will use the drug. Then will make the three tests and after will stop the drug by 1 month and come back to do the tests. We objective to demonstrate the washout of the drug clinically.

Drug: Dipeptidyl Peptidase IV inhibitors

Interventions

Dipeptidyl Peptidase IV inhibitors DRUG

Dosage 100 mg each day, once a day, 2 months

Also known as: Januvia (Merck Sharp Dome), Sitagliptin

1; 2

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Drug näive patients with T2DM (for the purpose of this study "drug näive" patients are defined as subjects who have never been treated with an oral antidiabetic agent or subjects who have not taken any antidiabetic agent for at least 12 weeks prior to study entry (Visit 1) and if they had never received antidiabetic agents then never for \> 3 months at any time in the past).
• Age in the range of 18 - 78 years inclusive.
• Male, non-fertile female or female of childbearing potential using a medically approved birth control method. A non-fertile female is defined as:
• post menopausal ( 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \>40mlU/m)
• weeks post bilateral oophorectomy with or without hysterectomy
• post hysterectomy
• or sterilized by tubal ligation.
• Written informed consent to participate in the study.
• Ability to comply with all study requirements.

You may not qualify if:

• Pregnant or lactating female
• A history of type 1 diabetes, diabetes that is result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing´s syndrome and acromegaly, acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
• Evidence of significant diabetic complications, e.g., symptomatic autonomic neuropathy or gastroparesis.
• Acute infections wich may affect blood glucose control within 4 weeks prior to visit 1 and other concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
• Any of the following within the past 6 months:
• myocardial infarction (MI) (if the visit one ECG reveals patterns consistent with a MI and the date of the event cannot be determined, then the patient can enter the study at the discretion of the investigator and the sponsor)
• coronary artery bypass surgery or percutaneous coronary intervention, unstable angina or stroke.
• Congestive heart failure (CHF) requiring pharmacological treatment.
• Any of the following EGC abnormalities; "Torsades de points", sustained and clinically relevant ventricular tachycardia or ventricular fibrillation, second degree AV block (Mobitz 1 and 2 ), third degree AV block, prolonged QTc (\>500 msec)
• Malignancy including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years.
• Liver disease such as cirrhosis or chronic active hepatitis.
• Donation of one unit ( 500ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
• Chronic insulin (\>4 weeks of treatment in the absence of an intercurrent illness) within the past 6 month.
• Chronic oral or parenteral corticosteroid treatment ( \> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
• Treatment with growth hormone or similar drugs.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• University of Sao Paulo: collaborator

Study Sites (1)

University of São Paulo General Hospital

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

• da Silva Schreiber C, Rafacho A, Silverio R, Betti R, Lerario AC, Lotenberg AMP, Rahmann K, de Oliveira CP, Wajchenberg BL, da Luz PL. The effects of macronutrients composition on hormones and substrates during a meal tolerance test in drugnaive and sitagliptin-treated individuals with type 2 diabetes: a randomized crossover study. Arch Endocrinol Metab. 2022 May 13;66(3):312-323. doi: 10.20945/2359-3997000000478. Epub 2022 May 12.

  PMID: 35551683 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Cristina S Oliveira, Pos Grad

  Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

• Bernardo L Wajchenberg, PhD

  Sao Paulo General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colaborator

Study Record Dates

• First Submitted: April 14, 2009
• First Posted: April 15, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: October 1, 2011
• Last Updated: May 28, 2012

Record last verified: 2012-05

Locations

BR (1)