Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy

An observational study of Diabetes Mellitus, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Diabetes Mellitus
What is being tested?: Distal pancreatectomy
Type of treatment: Surgery or procedure
How many people: 485 participants
Where: 1 siteChina
Study dates: 1 Jan 2004to 13 Feb 2016
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients undergoing distal pancreatectomy at our single tertiary referral hospital

Who may be able to join

Patients undergoing distal pancreatectomy

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
Beijing, 100730

Other trials in China

About this study

Read the 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.

Conditions: Diabetes Mellitus
Being tested: Distal pancreatectomy
Keywords: pancreatectomy, diabetes mellitus
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Distal pancreatectomyProcedure or surgery
Distal pancreatectomy with or without splenectomy using minimal invasive or open approach

Study groups in NCT03030209
Study group	Role	What they receive
Distal Pancreatectomy		Patients undergoing distal pancreatectomy Receives: Procedure: Distal pancreatectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with new-onset diabetes mellitus as defined by American Diabetes Association
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.
Measured: Through study completion, an average of 3 year

Secondary outcomes (2)

Number of participants with new-onset prediabetes as defined by American Diabetes Association
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)
Measured: Through study completion, an average of 3 year
Number of participants with new-onset exocrine insufficiency
Exocrine insufficiency is defined as patients requiring oral pancreatic enzyme replacement because of severe diarrhea.
Measured: Through study completion, an average of 3 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 200413 Feb 2016

First posted24 Jan 2017 (estimated)
Study start1 Jan 2004
Primary completion13 Feb 2016
Study completion13 Feb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 485 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03030209
Sponsor's protocol ID: PUMCH-GS03
Status last verified: Sep 2016
First submitted: 17 Sep 2016
Last updated: 2 Sep 2020
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Kwon JH, Kim SC, Shim IK, Song KB, Lee JH, Hwang DW, Park KM, Lee YJ. Factors Affecting the Development of Diabetes Mellitus After Pancreatic Resection. Pancreas. 2015 Nov;44(8):1296-303. doi: 10.1097/MPA.0000000000000404.
PubMed 26390413
Shirakawa S, Matsumoto I, Toyama H, Shinzeki M, Ajiki T, Fukumoto T, Ku Y. Pancreatic volumetric assessment as a predictor of new-onset diabetes following distal pancreatectomy. J Gastrointest Surg. 2012 Dec;16(12):2212-9. doi: 10.1007/s11605-012-2039-7. Epub 2012 Sep 28.
PubMed 23054900
King J, Kazanjian K, Matsumoto J, Reber HA, Yeh MW, Hines OJ, Eibl G. Distal pancreatectomy: incidence of postoperative diabetes. J Gastrointest Surg. 2008 Sep;12(9):1548-53. doi: 10.1007/s11605-008-0560-5. Epub 2008 Jun 10.
PubMed 18543045
You DD, Choi SH, Choi DW, Heo JS, Ho CY, Kim WS. Long-term effects of pancreaticoduodenectomy on glucose metabolism. ANZ J Surg. 2012 Jun;82(6):447-51. doi: 10.1111/j.1445-2197.2012.06080.x. Epub 2012 May 9.
PubMed 22571457
Dai M, Xing C, Shi N, Wang S, Wu G, Liao Q, Zhang T, Chen G, Wu W, Guo J, Liu Z. Risk factors for new-onset diabetes mellitus after distal pancreatectomy. BMJ Open Diabetes Res Care. 2020 Oct;8(2):e001778. doi: 10.1136/bmjdrc-2020-001778.
PubMed 33122295

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy
ClinicalTrials.gov ID: NCT03030209
Acronym / sponsor ID: PUMCH-GS03
Conditions: Diabetes Mellitus
Keywords: pancreatectomy, diabetes mellitus
Study type: Observational
Recruitment status: Completed
Enrolment: 485 participants (actual)
Lead sponsor: Peking Union Medical College HospitalUniversity, hospital or other
Study start: 1 Jan 2004 (actual)
Primary completion: 13 Feb 2016 (actual)
Study completion: 13 Feb 2016 (actual)
First posted: 24 Jan 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Distal Pancreatectomy	–	Procedure: Distal pancreatectomyPatients undergoing distal pancreatectomy

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients undergoing distal pancreatectomy at our single tertiary referral hospital

Key inclusion criteria (1 listed)

Patients undergoing distal pancreatectomy

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Distal pancreatectomyDistal pancreatectomy with or without splenectomy using minimal invasive or open approach	Procedure or surgery	Distal Pancreatectomy

Primary outcome

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.

2 secondary outcomes

Number of participants with new-onset prediabetes as defined by American Diabetes Association
Time frame: Through study completion, an average of 3 year
Number of participants with new-onset exocrine insufficiency
Time frame: Through study completion, an average of 3 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
Background: PubMed 26390413Kwon JH, Kim SC, Shim IK, Song KB, Lee JH, Hwang DW, Park KM, Lee YJ. Factors Affecting the Development of Diabetes Mellitus After Pancreatic Resection. Pancreas. 2015 Nov;44(8):1296-303. doi: 10.1097/MPA.0000000000000404.
Background: PubMed 23054900Shirakawa S, Matsumoto I, Toyama H, Shinzeki M, Ajiki T, Fukumoto T, Ku Y. Pancreatic volumetric assessment as a predictor of new-onset diabetes following distal pancreatectomy. J Gastrointest Surg. 2012 Dec;16(12):2212-9. doi: 10.1007/s11605-012-2039-7. Epub 2012 Sep 28.
Background: PubMed 18543045King J, Kazanjian K, Matsumoto J, Reber HA, Yeh MW, Hines OJ, Eibl G. Distal pancreatectomy: incidence of postoperative diabetes. J Gastrointest Surg. 2008 Sep;12(9):1548-53. doi: 10.1007/s11605-008-0560-5. Epub 2008 Jun 10.
Background: PubMed 22571457You DD, Choi SH, Choi DW, Heo JS, Ho CY, Kim WS. Long-term effects of pancreaticoduodenectomy on glucose metabolism. ANZ J Surg. 2012 Jun;82(6):447-51. doi: 10.1111/j.1445-2197.2012.06080.x. Epub 2012 May 9.
Derived from this study: PubMed 33122295Dai M, Xing C, Shi N, Wang S, Wu G, Liao Q, Zhang T, Chen G, Wu W, Guo J, Liu Z. Risk factors for new-onset diabetes mellitus after distal pancreatectomy. BMJ Open Diabetes Res Care. 2020 Oct;8(2):e001778. doi: 10.1136/bmjdrc-2020-001778.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Menghua Dai, M.D. study chair

Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with new-onset diabetes mellitus as defined by American Diabetes Association (time frame: Through study completion, an average of 3 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03030209, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.