ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 13522 for:    "Diabetes Mellitus"

Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03030209
Recruitment Status : Unknown
Verified September 2016 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : January 24, 2017
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
Glucose homeostasis changes after distal pancreatectomy are not well understood. This study aim to identify the incidence of and risk factors for, a change in glucose homeostasis in patients who underwent distal pancreatic resection.

Condition or disease Intervention/treatment
Diabetes Mellitus Procedure: Distal pancreatectomy

Detailed Description:
The development of sophisticated surgical procedures, improved postoperative care, and the capacity for early diagnosis of disease, have prolonged life expectancy after pancreatic resection. For these patients, the endocrine function of the pancreas is a critical factor that influences quality of life. In this study, the investigators recruit patients who underwent distal pancreatectomy in Peking Union Medical College Hospital within the last 10 years. Demographic characteristics, operative parameters and short-term postoperative outcomes were collected in a prospective database maintained by the Pancreatic Surgical Centre, Peking Union Medical College Hospital. These patients are followed up regularly by outpatient visiting or telephone for long-term outcomes. The primary outcome of this study is new-onset diabetes mellitus; second outcomes include impaired fasting glucose, impaired glucose tolerance, exocrine insufficiency and disease recurrence. This study aim to determine the cumulative rates of endocrine insufficiency, and identify risk factors for DM development in a large cohort of patients undergoing distal pancreatectomy.

Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy
Study Start Date : January 2000
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Group/Cohort Intervention/treatment
Distal Pancreatectomy
Patients undergoing distal pancreatectomy
Procedure: Distal pancreatectomy
Distal pancreatectomy with or without splenectomy using minimal invasive or open approach




Primary Outcome Measures :
  1. Number of participants with new-onset diabetes mellitus as defined by American Diabetes Association [ Time Frame: Through study completion, an average of 3 year ]

    The criteria for the diagnosis of diabetes developed by American Diabetes Association (1) FPG (fasting plasma glucose) ≥ 126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h.* OR (2) 2-h PG (plasma glucose) ≥ 200 mg/dL (11.1mmol/L) during an OGTT (oral glucose tolerance test). The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.* OR (3) A1C ≥ 6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay.* (lower-upper limit: 4.5%-6.3% in PUMCH) OR (4) In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dL (11.1 mmol/L).

    *In the absence of unequivocal hyperglycemia, results should be confirmed by repeat testing.



Secondary Outcome Measures :
  1. Number of participants with new-onset prediabetes as defined by American Diabetes Association [ Time Frame: Through study completion, an average of 3 year ]

    The categories of prediabetes (increased risk for diabetes)

    (1) Impaired fasting glucose (IFG): FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L). (3.6 - 6.1 mmol/L in PUMCH) OR (2) Impaired glucose tolerance (IGT): 2-h PG in the 75-g OGTT 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L). The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.

    OR (3) A1C 5.7-6.4% (39-46 mmol/mol)


  2. Number of participants with new-onset exocrine insufficiency [ Time Frame: Through study completion, an average of 3 year ]
    Exocrine insufficiency is defined as patients requiring oral pancreatic enzyme replacement because of severe diarrhea.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing distal pancreatectomy at our single tertiary referral hospital
Criteria

Inclusion Criteria:

  • Patients undergoing distal pancreatectomy

Exclusion Criteria:

  • Patients undergoing pancreaticoduodenectomy, middle pancreatectomy and enucleation
  • Patients with preoperative DM
  • Patients with functioning insulinoma and multiple endocrine neoplasia type 1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030209


Contacts
Contact: Menghua Dai, M.D. daimh@pumch.cn
Contact: Ning Shi, M.D. 008613693303585 shining_doc@163.com

Locations
China
Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China Recruiting
Beijing, China, 100730
Contact: Menghua Dai, M.D.       daimh@pumch.cn   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Study Chair: Menghua Dai, M.D. Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

Publications:
Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03030209     History of Changes
Other Study ID Numbers: PUMCH-GS03
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Peking Union Medical College Hospital:
pancreatectomy
diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases