Type 2 DiabetesNCT01153516

Diabetes and Gastric By- Pass

An observational study of Type 2 Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate the mechanisms leading to rapid postoperative improvement in diabetes following Gastric By-Pass surgery for obesity.We will evaluate and compare the changes in glucose level, beta-cell function, and insulin resistance induced by a week of very low calorie liquid diet and those… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Type 2 Diabetes
How many people: 22 participants
Where: 1 siteUnited States
Study dates: Jun 2010to Dec 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Bariatric surgery clinical roster or by the treating physician in the bariatric surgery clinic. This study does NOT pay for the By-pass surgery, eligible participants should have planned their surgery by their own physician, at their own expense.

Who may be able to join

volunteers that are planned to undergo RYGB(Roux-en-Y By pass) and have type 2 diabetes diagnosed within the prior 10 years.

Who cannot join

abnormal renal function
significant anemia
difficult venous access
treatment with incretin mimetics or DPP IV inhibitors in the prior 3 months
recent change in use of any pharmacologic agent with potential effect on either beta-cell function or insulin resistance.
pregnancy
non -English speakers

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical and Translational Research Center
Dallas, Texas, 75390

Other trials in United States

About this study

Official title: Unraveling the Mechanisms of Rapid Improvement in Diabetes Following Gastric By-Pass Surgery

Read the detailed description

Volunteers planned to undergo RYGB will be studied during two-9 days periods of identical and controlled diet and activity, separated by a 4-10-week washout period.

Study Period #1:

This first study period is 9 days/nights long and requires you to be closely supervised at our Clinical and Translational Research Center (CTRC). During this time you will receive the same diet and are expected to have the same activity level you will be prescribed in the immediate post-operative period.

Wash-out period:

During this study period you are expected to return to your usual diet and exercise level.

Study Period #2:

This last study period is also 9 days/nights long, includes the EXACT same diet you have received during the first study period, and in addition you will undergo the planned gastric by-pass surgery.

Procedures during the research:

Mixed Meal Challenge test will be done four times during the entire study: days 1 and 9 for each study period. This test allows the investigators to evaluate how much insulin your body is producing and how well this insulin is processed.

Measurement of resting energy expenditure will be done four times during the entire study. This test tell us how much energy your body is burning up in a resting state.

Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes, Bariatric surgery, Obesity, Weight loss
Medical subject headings: Diabetes Mellitus, Type 2, Obesity, Weight Loss

What is being measured

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

Response in Glucose AUC at Baseline vs. Following Gastric Bypass Surgery
Changes in the glucose Area Under the Curve (AUC) calculated as the difference between the initial evaluation (test 1, assessed at day 1) and the next evaluation (test 2, assessed at day 9) of study period 1. Subjects then underwent gastric bypass surgery approximately 4-10 weeks later. In study period 2 following surgery, changes in the glucose AUC was again calculated as the difference between the initial evaluation (test 3, assessed at day 1 following surgery) and the next evaluation (test 4, assessed at day 9 following surgery). Change in AUC in study period 1 was compared to change in AUC in study period 2.
Blood samples were collected at 5, 10, 15, 20, 25, 30, 40, 50, 60, 80, 100, 120, 150, 180, 210, 240, 300, and 360 minutes after the ingestion of 240 mL of chocolate Boost Plus Nestle.
Total AUC was computed using the trapezoidal rule.
Measured: 4-12 weeks
Response in Insulin AUC at Baseline vs Following Gastric Bypass Surgery
Changes in the Insulin Area Under the Curve (AUC) calculated as the difference between the initial evaluation (test 1, assessed at day 1) and the next evaluation (test 2, assessed at day 9) of study period 1. Subjects then underwent gastric bypass surgery approximately 4-10 weeks later. In study period 2 following surgery, changes in the insulin AUC was again calculated as the difference between the initial evaluation (test 3, assessed at day 1 following surgery) and the next evaluation (test 4, assessed at day 9 following surgery). Change in AUC in study period 1 was compared to change in AUC in study period 2.
Blood samples were collected at 5, 10, 15, 20, 25, 30, 40, 50, 60, 80, 100, 120, 150, 180, 210, 240, 300, and 360 minutes after the ingestion of 240 mL of chocolate Boost Plus Nestle.
Total AUC was computed using the trapezoidal rule.
Measured: 4-12 weeks
Response in Glucagon AUC at Baseline vs. Following Gastric Bypass
Changes in the glucagon Area Under the Curve (AUC) calculated as the difference between the initial evaluation (test 1, assessed at day 1) and the next evaluation (test 2, assessed at day 9) of study period 1. Subjects then underwent gastric bypass surgery approximately 4-10 weeks later. In study period 2 following surgery, changes in the glucagon AUC was again calculated as the difference between the initial evaluation (test 3, assessed at day 1 following surgery) and the next evaluation (test 4, assessed at day 9 following surgery). Change in AUC in study period 1 was compared to change in AUC in study period 2.
Blood samples were collected at 5, 10, 15, 20, 25, 30, 40, 50, 60, 80, 100, 120, 150, 180, 210, 240, 300, and 360 minutes after the ingestion of 240 mL of chocolate Boost Plus Nestle.
Total AUC was computed using the trapezoidal rule.
Measured: 4-12 weeks

Timeline

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

Jun 2010Dec 2012

First posted30 Jun 2010 (estimated)
Study startJun 2010
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
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: Case crossover
Time perspective: Prospective
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01153516
Sponsor's protocol ID: 122009-049
Status last verified: Mar 2019
First submitted: 24 Jun 2010
Last updated: 27 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lingvay I, Guth E, Islam A, Livingston E. Rapid improvement in diabetes after gastric bypass surgery: is it the diet or surgery? Diabetes Care. 2013 Sep;36(9):2741-7. doi: 10.2337/dc12-2316. Epub 2013 Mar 25.
PubMed 23530013

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?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Unraveling the Mechanisms of Rapid Improvement in Diabetes Following Gastric By-Pass Surgery
ClinicalTrials.gov ID: NCT01153516
Acronym / sponsor ID: 122009-049
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes, Bariatric surgery, Obesity, Weight loss
Study type: Observational
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Study start: Jun 2010
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 30 Jun 2010 (estimated)
Results: Posted 7 Mar 2019

Clinical summary

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

Detailed description

Volunteers planned to undergo RYGB will be studied during two-9 days periods of identical and controlled diet and activity, separated by a 4-10-week washout period.

Study Period #1:

Wash-out period:

During this study period you are expected to return to your usual diet and exercise level.

Study Period #2:

This last study period is also 9 days/nights long, includes the EXACT same diet you have received during the first study period, and in addition you will undergo the planned gastric by-pass surgery.

Procedures during the research:

Measurement of resting energy expenditure will be done four times during the entire study. This test tell us how much energy your body is burning up in a resting state.

Study design

Observational model: Case crossover
Time perspective: Prospective

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Bariatric surgery clinical roster or by the treating physician in the bariatric surgery clinic. This study does NOT pay for the By-pass surgery, eligible participants should have planned their surgery by their own physician, at their own expense.

Key inclusion criteria (1 listed)

volunteers that are planned to undergo RYGB(Roux-en-Y By pass) and have type 2 diabetes diagnosed within the prior 10 years.

Key exclusion criteria (7 listed)

abnormal renal function
significant anemia
difficult venous access
treatment with incretin mimetics or DPP IV inhibitors in the prior 3 months
recent change in use of any pharmacologic agent with potential effect on either beta-cell function or insulin resistance.

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

Primary outcome

Response in Glucose AUC at Baseline vs. Following Gastric Bypass Surgery
Time frame: 4-12 weeks
Changes in the glucose Area Under the Curve (AUC) calculated as the difference between the initial evaluation (test 1, assessed at day 1) and the next evaluation (test 2, assessed at day 9) of study period 1. Subjects then underwent gastric bypass surgery approximately 4-10 weeks later. In study period 2 following surgery, changes in the glucose AUC was again calculated as the difference between the initial evaluation (test 3, assessed at day 1 following surgery) and the next evaluation (test 4, assessed at day 9 following surgery). Change in AUC in study period 1 was compared to change in AUC in study period 2. Blood samples were collected at 5, 10, 15, 20, 25, 30, 40, 50, 60, 80, 100, 120, 150, 180, 210, 240, 300, and 360 minutes after the ingestion of 240 mL of chocolate Boost Plus Nestle. Total AUC was computed using the trapezoidal rule.
Response in Insulin AUC at Baseline vs Following Gastric Bypass Surgery
Time frame: 4-12 weeks
Changes in the Insulin Area Under the Curve (AUC) calculated as the difference between the initial evaluation (test 1, assessed at day 1) and the next evaluation (test 2, assessed at day 9) of study period 1. Subjects then underwent gastric bypass surgery approximately 4-10 weeks later. In study period 2 following surgery, changes in the insulin AUC was again calculated as the difference between the initial evaluation (test 3, assessed at day 1 following surgery) and the next evaluation (test 4, assessed at day 9 following surgery). Change in AUC in study period 1 was compared to change in AUC in study period 2. Blood samples were collected at 5, 10, 15, 20, 25, 30, 40, 50, 60, 80, 100, 120, 150, 180, 210, 240, 300, and 360 minutes after the ingestion of 240 mL of chocolate Boost Plus Nestle. Total AUC was computed using the trapezoidal rule.
Response in Glucagon AUC at Baseline vs. Following Gastric Bypass
Time frame: 4-12 weeks
Changes in the glucagon Area Under the Curve (AUC) calculated as the difference between the initial evaluation (test 1, assessed at day 1) and the next evaluation (test 2, assessed at day 9) of study period 1. Subjects then underwent gastric bypass surgery approximately 4-10 weeks later. In study period 2 following surgery, changes in the glucagon AUC was again calculated as the difference between the initial evaluation (test 3, assessed at day 1 following surgery) and the next evaluation (test 4, assessed at day 9 following surgery). Change in AUC in study period 1 was compared to change in AUC in study period 2. Blood samples were collected at 5, 10, 15, 20, 25, 30, 40, 50, 60, 80, 100, 120, 150, 180, 210, 240, 300, and 360 minutes after the ingestion of 240 mL of chocolate Boost Plus Nestle. Total AUC was computed using the trapezoidal rule.

Results and safety

Results posted to the registry on 7 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diet Only Group	12	10
Surgery and Diet Group	10	10

Primary outcome: Response in Glucose AUC at Baseline vs. Following Gastric Bypass Surgery

Time frame: 4-12 weeks. Mean (95% Confidence Interval). Unit: mg/dL*min

Measure	Diet Only Group n = 10	Surgery and Diet Group n = 10
Value	61647.0 (47023.3 to 76270.8)	59476.1 (47943.8 to 71008.4)

Primary outcome: Response in Insulin AUC at Baseline vs Following Gastric Bypass Surgery

Time frame: 4-12 weeks. Mean (95% Confidence Interval). Unit: uIU/mL*min

Measure	Diet Only Group n = 10	Surgery and Diet Group n = 10
Value	7888.6 (5505.19 to 10272.08)	4259.3 (3262.1 to 5256.4)

Primary outcome: Response in Glucagon AUC at Baseline vs. Following Gastric Bypass

Time frame: 4-12 weeks. Mean (95% Confidence Interval). Unit: pg/mL*min

Measure	Diet Only Group n = 10	Surgery and Diet Group n = 10
Value	24332.8 (20624.3 to 28041.3)	32929.1 (25920.5 to 39937.8)

Adverse events

Time frame: 18 days. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diet Only Group	0 of 12 (0%)	1 of 12 (8.3%)	Not reported
Surgery and Diet Group	0 of 10 (0%)	0 of 10 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23530013Lingvay I, Guth E, Islam A, Livingston E. Rapid improvement in diabetes after gastric bypass surgery: is it the diet or surgery? Diabetes Care. 2013 Sep;36(9):2741-7. doi: 10.2337/dc12-2316. Epub 2013 Mar 25.

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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.

Ildiko Lingvay, MD, MPH, MSCS principal investigator

UT Southwestern Medical Center, Dallas

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 Type 2 Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.

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 7 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 27 Mar 2019. 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 United States. 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?

Yes. Results are posted in the registry (first posted 7 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Response in Glucose AUC at Baseline vs. Following Gastric Bypass Surgery (time frame: 4-12 weeks). The study lists 3 primary outcomes in all. 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 NCT01153516, which also lists 1 linked publication.

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 27 Mar 2019.