Type 2 Diabetes MellitusNCT01882036
Bariatric Surgery And Adipose Inflammation Dysfunction and Type 2 Diabetes Mellitus
A study testing Gastric Bypass w/ matched hypocaloric diet and Hypocaloric diet in people with Type 2 Diabetes Mellitus and Insulin Resistance, run by University of Minnesota at 1 site in United States.
Trial summary
The focus of this proposal is to define the mechanism by which bariatric surgery acutely improves insulin sensitivity. Our central hypothesis is that drastically reduced caloric intake early after Bariatric surgery improves the pro-inflammatory profile of macrophages, which in turn improves insulin sensitivity and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Insulin Resistance
- What is being tested?
- Gastric Bypass w/ matched hypocaloric diet and Hypocaloric diet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to 10 Jul 2018
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidate for RYGB gastric bypass with insurance approval.
- Willing to accept randomization to either immediate surgery, or delayed surgery after diet study.
- Willing to undergo two sessions of testing before, and ten days after surgery (or initiation of dietary intervention).
- BMI 35-45kg/m2
- Pre-diabetes (ADA criteria) or T2DM with HbA1c< 8%.
Who cannot join
- T1DM.
- Serious illness such as cancer, active chronic infection, cardiovascular disease greater that New York Heart Association class 2, chronic renal failure, chronic lung disease.
- Inflammatory or celiac intestinal disease.
- Untreated thyroid disease.
- Serious psychiatric disease.
- Excessive alcohol use.
- Illicit drug use. -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: The Effects of Roux-en-Y Gastric Bypass on Mitochondrial Dysfunction and Type 2 Diabetes Mellitus
The focus of this proposal is to define the mechanism by which bariatric surgery acutely improves insulin sensitivity. Our central hypothesis is that drastically reduced caloric intake early after Bariatric surgery improves the pro-inflammatory profile of macrophages, which in turn improves insulin sensitivity and glucose homeostasis.
Read the detailed description
Bariatric surgery quickly improves tissue specific insulin sensitivity. Changes in glucose metabolism are seen within days after surgery, prior to any significant weight loss--raising the question of a difference between dietary restriction and early food intake after surgery. A major factor in the development of insulin resistance is obesity. It has been noted that by 3 months following Roux-en Y gastric bypass surgery in obese patients with (T2DM), fasting glucose and insulin levels are improved independent of weight loss, insulin resistance in muscle is lowered, and that the pro-inflammatory profile of resident microphages is lowered improving insulin sensitivity.
The focus of this proposal is to define the mechanism by which bariatric surgery improves impacts insulin sensitivity. Our long-term goal is to correlate these changes with direct measures of adipose tissue insulin resistance to develop novel immunotherapies towards reducing insulin resistance without surgery.
Our central hypothesis is that gastrointestinal rearrangement by various mechanisms impacts adipose tissue and improves the pro-inflammatory profile of macrophages improving insulin sensitivity and glucose homeostasis. To test this hypothesis we propose the following aims:
Specific Aim 1. Recruit a patient population and measure insulin sensitivity using homeostatic model assessment (HOMA) to measure insulin resistance (IR), cytokines, incretins, and serum adipokines in morbidly obese patients • prior to and 7-10 days following bariatric surgery while on a hypocaloric diet (surgery group) and •prior to and 7-10 days while following hypocaloric diet similar to bariatric surgery (diet group). Subjects will be assigned to the two arms; subjects assigned to the hypocaloric diet may be offered bariatric surgery after completion of the diet.
Specific Aim 2.
- Profile inflammatory macrophages, T cells and secreted factors in subcutaneous and visceral adipose tissue of patients prior to and following RYGB and hypocaloric diet treatments. • prior to and 7-10 days following surgery
- prior to and 7-10 days following hypocaloric diet similar to bariatric surgery
Specific Aim 3.
Assess the effects of bariatric surgery on ROS (reactive oxygen species) production, expression of transcription factors and enzymes of mitochondrial biogenesis, tissue FABP4, and biomarkers of oxidative stress and protein carbonylation in patients prior to and following surgery and in control diet subjects maintained on hypocaloric diet.
Specific Aim 4.
Determine the impact of bariatric surgery on lipolysis and the role of TLQP-21 (a genetically derived peptide that increases energy expenditure and prevents the early phase of diet-induced obesity).
- Conditions
- Type 2 Diabetes Mellitus, Insulin Resistance
- Being tested
- Gastric Bypass w/ matched hypocaloric diet, Hypocaloric diet
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric Bypass w/ matched hypocaloric dietProcedure or surgery
Roux en Y Gastric Bypass with Hypocaloric liquid diet for 10 days
Hypocaloric dietOther
Hypocaloric liquid diet for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Gastric Bypass w/ matched hypocaloric diet | Active comparator | Not described Receives: Procedure: Gastric Bypass w/ matched hypocaloric diet |
| Hypocaloric Diet | Active comparator | Not described Receives: Other: Hypocaloric diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure homeostasis model assessment i.e. estimated change in insulin resistance (HOMA-IR) index
Measured: Seven days before and 10 days following RYGB or hypocaloric diet similar to RYGB patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startNov 2011
- Primary completion10 Jul 2018
- Study completion10 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Sayeed Ikramuddin, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882036
- Sponsor's protocol ID
- SURG-2018-26725
- Status last verified
- Feb 2023
- First submitted
- 21 Jun 2012
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Roux-en-Y Gastric Bypass on Mitochondrial Dysfunction and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01882036
- Acronym / sponsor ID
- SURG-2018-26725
- Conditions
- Type 2 Diabetes Mellitus, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Nov 2011 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 20 Jun 2013 (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.
The focus of this proposal is to define the mechanism by which bariatric surgery acutely improves insulin sensitivity. Our central hypothesis is that drastically reduced caloric intake early after Bariatric surgery improves the pro-inflammatory profile of macrophages, which in turn improves insulin sensitivity and glucose homeostasis.
Detailed description
Bariatric surgery quickly improves tissue specific insulin sensitivity. Changes in glucose metabolism are seen within days after surgery, prior to any significant weight loss--raising the question of a difference between dietary restriction and early food intake after surgery. A major factor in the development of insulin resistance is obesity. It has been noted that by 3 months following Roux-en Y gastric bypass surgery in obese patients with (T2DM), fasting glucose and insulin levels are improved independent of weight loss, insulin resistance in muscle is lowered, and that the pro-inflammatory profile of resident microphages is lowered improving insulin sensitivity.
The focus of this proposal is to define the mechanism by which bariatric surgery improves impacts insulin sensitivity. Our long-term goal is to correlate these changes with direct measures of adipose tissue insulin resistance to develop novel immunotherapies towards reducing insulin resistance without surgery.
Our central hypothesis is that gastrointestinal rearrangement by various mechanisms impacts adipose tissue and improves the pro-inflammatory profile of macrophages improving insulin sensitivity and glucose homeostasis. To test this hypothesis we propose the following aims:
Specific Aim 1. Recruit a patient population and measure insulin sensitivity using homeostatic model assessment (HOMA) to measure insulin resistance (IR), cytokines, incretins, and serum adipokines in morbidly obese patients • prior to and 7-10 days following bariatric surgery while on a hypocaloric diet (surgery group) and •prior to and 7-10 days while following hypocaloric diet similar to bariatric surgery (diet group). Subjects will be assigned to the two arms; subjects assigned to the hypocaloric diet may be offered bariatric surgery after completion of the diet.
Specific Aim 2.
- Profile inflammatory macrophages, T cells and secreted factors in subcutaneous and visceral adipose tissue of patients prior to and following RYGB and hypocaloric diet treatments. • prior to and 7-10 days following surgery
- prior to and 7-10 days following hypocaloric diet similar to bariatric surgery
Specific Aim 3.
Assess the effects of bariatric surgery on ROS (reactive oxygen species) production, expression of transcription factors and enzymes of mitochondrial biogenesis, tissue FABP4, and biomarkers of oxidative stress and protein carbonylation in patients prior to and following surgery and in control diet subjects maintained on hypocaloric diet.
Specific Aim 4.
Determine the impact of bariatric surgery on lipolysis and the role of TLQP-21 (a genetically derived peptide that increases energy expenditure and prevents the early phase of diet-induced obesity).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric Bypass w/ matched hypocaloric diet | Active comparator | Procedure: Gastric Bypass w/ matched hypocaloric diet |
| Hypocaloric Diet | Active comparator | Other: Hypocaloric diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Candidate for RYGB gastric bypass with insurance approval.
- Willing to accept randomization to either immediate surgery, or delayed surgery after diet study.
- Willing to undergo two sessions of testing before, and ten days after surgery (or initiation of dietary intervention).
- BMI 35-45kg/m2
- Pre-diabetes (ADA criteria) or T2DM with HbA1c< 8%.
Key exclusion criteria (7 listed)
- T1DM.
- Serious illness such as cancer, active chronic infection, cardiovascular disease greater that New York Heart Association class 2, chronic renal failure, chronic lung disease.
- Inflammatory or celiac intestinal disease.
- Untreated thyroid disease.
- Serious psychiatric disease.
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 |
|---|---|---|
| Gastric Bypass w/ matched hypocaloric dietRoux en Y Gastric Bypass with Hypocaloric liquid diet for 10 days | Procedure or surgery | Gastric Bypass w/ matched hypocaloric diet |
| Hypocaloric dietHypocaloric liquid diet for 10 days | Other | Hypocaloric Diet |
Primary outcome
Measure homeostasis model assessment i.e. estimated change in insulin resistance (HOMA-IR) index
Time frame: Seven days before and 10 days following RYGB or hypocaloric diet similar to RYGB patients
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 14 Feb 2023.
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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.
Sayeed Ikramuddin, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric Bypass w/ matched hypocaloric diet and Hypocaloric diet in people with Type 2 Diabetes Mellitus and Insulin Resistance, run by University of Minnesota 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 5 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 14 Feb 2023. 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?
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?
Measure homeostasis model assessment i.e. estimated change in insulin resistance (HOMA-IR) index (time frame: Seven days before and 10 days following RYGB or hypocaloric diet similar to RYGB patients). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2023.