Adipose Tissue Dysfunction Type 2 Diabetes Mellitus Bariatric SurgeryADIDYSNCT05291013
Adipose Tissue Dysfunction in Type 2 Diabetes and Its Reversibility by Bariatric Surgery
A study testing Gastric byspass in people with Adipose Tissue Dysfunction Type 2 Diabetes Mellitus Bariatric Surgery, run by Odense University Hospital at 1 site in Denmark.
Trial summary
ABSTRACT Background: Insulin resistance (IR) plays a major role in the pathogenesis of type 2 diabetes (T2D). Adipose tissue (AT) dysfunction leading to systemic low-grade inflammation and ectopic lipid deposition plays an important role in obesity-induced IR, but its role in T2D pathogenesis and to what extent… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Adipose Tissue Dysfunction Type 2 Diabetes Mellitus Bariatric Surgery
- What is being tested?
- Gastric byspass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2022to 30 Apr 2023
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GAD65 antibody negative patients with T2D
- Treated with either diet alone or diet in combination with metformin, DPP-4 inhibitors, sulphonylureas, GLP1-analogs or insulin (maximum 40 IE long - or intermediate acting insulin).
- HbA1c < 70 mmol/l for diabetics and <48 mmol/l for obese.
- Do not have any known diabetic complication (macroalbuminuria, proliferative retinopathy, neuropathy or cardiovascular disease).
- The use of up to two antihypertensive drugs and one cholesterol lowering drug is allowed in patients with T2D and obese individuals.
- Both patients with T2D and obese individuals should be eligible for bariatric surgery, and should be able and willing to discontinue all drugs for 1 week prior to the clamp studies
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- Except for the conditions mentioned above, the patients with T2D and the obese individuals should be healthy.
- Lean controls should be healthy, lean and drug naive.
- Obese and lean controls should have no first degree family history of diabetes.
- All participants should be 30-65 years old.
- All participants should be able to provide informed written consent.
Who cannot join
- Any unknown disease or need for medication that occurs after inclusion.
- Abnormal ECG, screening blood tests and/or severe hypertension (>160/100 mmHg).
- Impaired glucose tolerance (IGT) or impaired fasting glucose in lean, healthy participants (2-hour plasma glucose > 7.8 mmol/l or fasting plasma glucose > 5.6 mmol/l).
- Known pregnancy or positive beta-HCG in blood during screening.
Trial locations and contacts
1 site in 1 country.
Kurt Højlund, Professor, consultant doctor contact
Denmark1 site, 1 recruiting
- Recruiting
Kristoffer Jensen Kolnes
Odense, 5000
Kristoffer J Kolnes, Doctor, 93988934, kristoffer.jensen.kolnes@rsyd.dk
Tine Hylle, secretary, +4523741691, tine.hylle@rsyd.dk
About this study
ABSTRACT Background: Insulin resistance (IR) plays a major role in the pathogenesis of type 2 diabetes (T2D). Adipose tissue (AT) dysfunction leading to systemic low-grade inflammation and ectopic lipid deposition plays an important role in obesity-induced IR, but its role in T2D pathogenesis and to what extent insulin-sensitizing interventions can reverse AT dysfunction remain to be clarified.
Hypothesis/aims: To test the hypotheses 1) that T2D is associated with exaggerated AT dysfunction compared with obesity alone, 2) that increased insulin sensitivity and remission of T2D after bariatric surgery is in part explained by improved AT function Research plan: Novel markers of exaggerated AT dysfunction will be identified and studied together with known markers of AT dysfunction in patients with T2D compared with non-diabetic obese and lean individuals. Then the effects of bariatric surgery on all these markers of AT dysfunction in obesity and T2D will be studied. Adipose tissue and skeletal muscle biopsies and blood samples will be used for 1) next generation RNA sequencing, 2) targeted analysis of mRNA and protein content/activities, 3) metabolomics, 4) morphological analysis and 5) analysis of adipokines/myokines. Abnormalities in T2D and changes in response to bariatric surgery will be related to substrate metabolism, insulin sensitivity and secretion and insulin signalling in muscle.
Perspectives: This project provides novel insight into the role of AT dysfunction in T2D pathogenesis in humans and the potential of bariatric surgery to reverse AT dysfunction and improve insulin sensitivity. We ultimately expect that this will help us to identify novel pharmaceutical targets for the treatment of IR.
- Being tested
- Gastric byspass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric byspassProcedure or surgery
Test will be before and 9-12 month after gastric bypass
| Study group | Role | What they receive |
|---|---|---|
| Gastric bypass with T2DM | Experimental | Not described Receives: Procedure: Gastric byspass |
| Gastric bypass without T2DM | Experimental | Not described Receives: Procedure: Gastric byspass |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers in adipose tissue dysfunction
Changes in morphology of adipocytes, mRNA expression and protein abundance in adipocytes
Measured: 3 year
Muscular insulin sensitivity
Changes in muscle mRNA expression and protein abundance
Measured: 3 year
Secondary outcomes (3)
Rate of disposal
Changes in rate of disposal
Measured: 3 year
Body composition
Changes in body composition
Measured: 3 year
Metabolomics
Changes in metabolomics
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Jul 2022 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adipose Tissue Dysfunction Type 2 Diabetes Mellitus Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Odense University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristoffer Jensen Kolnes, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291013
- Sponsor's protocol ID
- S-20190162
- Acronym
- ADIDYS
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Tissue Dysfunction in Type 2 Diabetes and Its Reversibility by Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05291013
- Acronym / sponsor ID
- ADIDYS / S-20190162
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 22 Mar 2022 (actual)
- 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.
ABSTRACT Background: Insulin resistance (IR) plays a major role in the pathogenesis of type 2 diabetes (T2D). Adipose tissue (AT) dysfunction leading to systemic low-grade inflammation and ectopic lipid deposition plays an important role in obesity-induced IR, but its role in T2D pathogenesis and to what extent insulin-sensitizing interventions can reverse AT dysfunction remain to be clarified.
Hypothesis/aims: To test the hypotheses 1) that T2D is associated with exaggerated AT dysfunction compared with obesity alone, 2) that increased insulin sensitivity and remission of T2D after bariatric surgery is in part explained by improved AT function Research plan: Novel markers of exaggerated AT dysfunction will be identified and studied together with known markers of AT dysfunction in patients with T2D compared with non-diabetic obese and lean individuals. Then the effects of bariatric surgery on all these markers of AT dysfunction in obesity and T2D will be studied. Adipose tissue and skeletal muscle biopsies and blood samples will be used for 1) next generation RNA sequencing, 2) targeted analysis of mRNA and protein content/activities, 3) metabolomics, 4) morphological analysis and 5) analysis of adipokines/myokines. Abnormalities in T2D and changes in response to bariatric surgery will be related to substrate metabolism, insulin sensitivity and secretion and insulin signalling in muscle.
Perspectives: This project provides novel insight into the role of AT dysfunction in T2D pathogenesis in humans and the potential of bariatric surgery to reverse AT dysfunction and improve insulin sensitivity. We ultimately expect that this will help us to identify novel pharmaceutical targets for the treatment of IR.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gastric bypass with T2DM | Experimental | Procedure: Gastric byspass |
| Gastric bypass without T2DM | Experimental | Procedure: Gastric byspass |
| Control group | No intervention | – |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- GAD65 antibody negative patients with T2D
- Treated with either diet alone or diet in combination with metformin, DPP-4 inhibitors, sulphonylureas, GLP1-analogs or insulin (maximum 40 IE long - or intermediate acting insulin).
- HbA1c < 70 mmol/l for diabetics and <48 mmol/l for obese.
- Do not have any known diabetic complication (macroalbuminuria, proliferative retinopathy, neuropathy or cardiovascular disease).
- The use of up to two antihypertensive drugs and one cholesterol lowering drug is allowed in patients with T2D and obese individuals.
Key exclusion criteria (4 listed)
- Any unknown disease or need for medication that occurs after inclusion.
- Abnormal ECG, screening blood tests and/or severe hypertension (>160/100 mmHg).
- Impaired glucose tolerance (IGT) or impaired fasting glucose in lean, healthy participants (2-hour plasma glucose > 7.8 mmol/l or fasting plasma glucose > 5.6 mmol/l).
- Known pregnancy or positive beta-HCG in blood during screening.
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 byspassTest will be before and 9-12 month after gastric bypass | Procedure or surgery | Gastric bypass with T2DM, Gastric bypass without T2DM |
Primary outcome
Markers in adipose tissue dysfunction
Time frame: 3 year
Changes in morphology of adipocytes, mRNA expression and protein abundance in adipocytes
Muscular insulin sensitivity
Time frame: 3 year
Changes in muscle mRNA expression and protein abundance
3 secondary outcomes
Rate of disposal
Time frame: 3 year
Body composition
Time frame: 3 year
Metabolomics
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Adipose Tissue Dysfunction Type 2 Diabetes Mellitus Bariatric Surgery
RecruitingObservational study
Regional Adipose Tissue Characteristics in Type II Diabetes
Obesity and Type 2 Diabetes, Bariatric Patients Undergoing Bariatric Surgery
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.
Kurt Højlund, Professor, consultant doctor contact
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 byspass in people with Adipose Tissue Dysfunction Type 2 Diabetes Mellitus Bariatric Surgery, run by Odense University Hospital at 1 site in Denmark.
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 11 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Mar 2022. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristoffer Jensen Kolnes, MD, PhD-student (+4593988934, kristoffer.jensen.kolnes@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Markers in adipose tissue dysfunction (time frame: 3 year). The study lists 2 primary outcomes in all. 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 22 Mar 2022; AzTrials last refreshed its copy on 3 Nov 2026.