Effect of DPP-IV Inhibitor on Glycemic Control and Autonomic Neuropathy in Adult Patients With Diabetes Mellitus

NCT01545024 | Unknown

• 1 other identifier: 4-Kamoi
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Rocca et al. reported first that the secretion of incretins, particular GLP-1 in rat is regulated by the enteric nervous system, the afferent and efferent vagus nerves \[1\]. Further, Kazakos et al. \[2\] reported that autonomic nerve disturbance (AND) in patients with T2DM impaired the incretin effect owing to decreased GLP-1 secretion. However, Toft-Nielsen et al. \[3\] reported that the decreased GLP-1 responses in the patients with type 2 diabetes mellitus (T2DM) are unlikely to be related to the AND and, thus, did not support the results of Rocca et al. and Kazakos et al. Recently, Yabe at al. \[4\] also observed the same observations in Japanese patients with T2DM. Meanwhile, Jin et al. reported that administration of DPP-IV inhibitor recovered the disturbance of diabetic nerve dysfunction in rat \[5\]. However, it is unknown whether the administration of DPP-IV inhibitor effects on the AND in human, although many studies are performed to investigate the effect of the DPP-IV inhibitors on glycemic control. Accordingly, it is significant to reinvestigate an effect of DPP-IV inhibitor on glycemic control and autonomic neuropathy in diabetic patients.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Glycemic control

  As marker of HbA1c

  For one year after treatment wih DPP-IV inhibitor

Secondary Outcomes (1)

• autonomic nerve disturbance

  Before and one year after treatment with DPP-IV inhibitor

Study Arms (1)

DPP-IV inhibitor

Drug: Sitagliptin, 50 mg once per day per os

Interventions

Sitagliptin, 50 mg once per day per os DRUG

Before and one year after treatment with DPP-IV inhibitor in diabetic patients with AND.

Also known as: Nothing

DPP-IV inhibitor

Eligibility Criteria

• Age: 20 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Type 1 and 2 diabetic patients who have AND determined by C.V. R-R, outpatients regularly visiting hospital and more than 20 years old (gender is disregarded). Type 1 diabetic patients are treated with Epalrestat 50 mg. 150 mg t.i.d., while type 2 diabetic patients are treated with DPP-IV inhibitors.

You may qualify if:

• type 1 and 2 diabetes mellitus patients
• Patients who have AND determined by C.V. R-R.
• Outpatients regularly visiting hospital
• Patients 20 years old (gender is disregarded)

You may not qualify if:

• Patients with a serious complication in the heart, liver or kidney
• Pregnant or possibly pregnant patients, or lactating patients
• Patients complicated with a malignant tumor at present.
• Patients participating in other clinical study.
• Other than the above, patients judged inappropriate as the subjects of this study by the investigator

Sponsors & Collaborators

• Nagaoka Red Cross Hospital: lead

Study Sites (1)

Nagaoka Red Cross Hospital

Nagaoka, Niigata, 940-2085, Japan

RECRUITING

Related Publications (1)

• 1. Rocca AS, Brubaker PL. Role of the vagus nerve in mediating proximal nutrient-induced glucagon-like peptide-1 secretion. Endocrinology 1999;140:1687-1694. 2. Kazakos KA, Sarafidis PA, Yovos JG. The impact of diabetic autonomic neuropathy on the incretin effect. Med Sci Monit 2008; 14:CR213-220. 3. Toft-Nielsen MB, Damholt MB, Madsbad S, Hilsted LM, Hughes TE, Michelsen BK, Holst JJ. Determinants of the impaired secretion of glucagon-like peptide-1 in type 2 diabetic Patients. J Clin Endocrinol Metab 2001;86:3717-3723. 4. Yabe D, Watanabe K, Sugawara K, Kuwata H, Kitamoto Y, Sugizaki K, Fujiwara S, Hishizawa M, Hyo T, Kuwabara K, Yokota K, Iwasaki M, Kitatani N, Kurose T, Inagaki N, Seino Y (2011) Comparison of incretin immunoassays with or without plasma extraction: incretin secretion in Japanese patients with type 2 diabetes. J Diabetes Invest 2011;2:DOI. 5. Jin HY, Liu WJ, Park JH, Baek HS, Park TS. Effect of dipeptidyl peptidase-IV (DPP-IV) inhibitor (Vildagliptin) on peripheral nerves in streptozotocin-induced diabetic rats. Arch Med Res 2009;40:536-544.

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Kyuzi Kamoi, MD

  Nagaoka Red Cross Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyuzi Kamoi, MD

CONTACT

-81-0258-28-3600; kkam-int@echigo.ne.jp

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: March 6, 2012
• Study Start: September 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: March 14, 2012

Record last verified: 2012-02

Locations

JP (1)