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Effect of intervention with DMR, GLP-1 and lifestyle intensification -in subjects with insulin dependent type 2 diabetes- on insulin requirement and metabolic parameters


- candidate number27821
- NTR NumberNTR6674
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-sep-2017
- Secondary IDsABR number NL 60669.018.17
- Public TitleEffect of intervention with DMR, GLP-1 and lifestyle intensification -in subjects with insulin dependent type 2 diabetes- on insulin requirement and metabolic parameters
- Scientific TitleEffect of INtervention with DMR, GLP-1 and lifestyle intensification -in Subjects with insulin dePendent type 2 diabetes- on Insulin Requirement and mEtabolic parameters
- ACRONYMINSPIRE
- hypothesisThe objective of this pilot study is to evaluate the effect of the Duodenal Mucosal Resurfacing procedure combined with GLP-1 administration and lifestyle intervention in subjects with insulin dependent type 2 diabetes and an adequate beta-cell reserve. The aimed effect is an adequate glucose regulation without the need of insulin therapy. Secondary effects include improved cardiovascular, hepatological and metabolic parameters.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Insulin resistance, Non alcoholic steato hepatitis (NASH), Cardiovascular health
- Inclusion criteria1. Diagnosed with Type 2 Diabetes
2. 28 -75 years of age
3. Treatment with long acting insulin ≤ 2 years
4. On daily long acting insulin dose ≤ 1 U/kg
5. BMI ≥ 24 and ≤ 40 kg/m2
6. HbA1c ≤ 8.0% (64 mmol/mol)
7. Fasting C-peptide ≥ 500 pmol/L (1.5 ng/ml)
8. Willing to comply with study requirements and able to understand and comply with informed consent
- Exclusion criteria1. Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
2. Fasting C-peptide < 500 pmol/L (1.5 ng/ml)
3. Current use of multiple daily doses insulin or insulin pump
4. Current use of a sulfonylurea derivate or meglitinide
5. Known autoimmune disease, as evidenced by a positive Anti-GAD test, including Celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
6. Previous GI surgery that could affect the ability to treat the duodenum such as subjects who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions
7. History of chronic or acute pancreatitis
8. Known active hepatitis or active liver disease
9. Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn's Disease and Celiac Disease
10.History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
11.Use of anticoagulation therapy (such as phenprocoumon and acenocoumarol) and novel oral anticoagulants (such as rivaroxaban, apixaban, edoxaban and dabigatran) which cannot be discontinued for 7 days before and 14 days after the procedure
12.Use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure. Use of aspirin is allowed.
13.Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 4 weeks post procedure phase
14.Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)
15.Receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
16.Persistent Anemia, defined as Hgb < 10 g/dl
17.eGFR or MDRD < 30 ml/min/1.73m^2
18.Active systemic infection
19.Active malignancy within the last 5 years
20.Not potential candidates for surgery or general anesthesia
21.Active illicit substance abuse or alcoholism
22.Participating in another ongoing clinical trial of an investigational drug or device
23.Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 15-sep-2017
- planned closingdate1-mrt-2019
- Target number of participants16
- InterventionsDuodenal mucosal resurfacing (DMR),
stop long-acting insulin therapy,
start GLP-1 agonist(liraglutide),
start lifestyle intensification (nutrition and lifestyle counseling)
- Primary outcomeProtocol driven free of insulin at 6 months including and an HbA1c ≤ 7.5%.
- Secondary outcomeThe following secondary endpoints are evaluated to identify improvement in cardiovascular, metabolic and hepatic parameters:
•HbA1c (at screening and at 3, 6, 12 months follow-up)
•Change in HbA1c (at 3, 6,9, 12 months follow-up)
•Achieving target HbA1c of 7.0% (53 mmol/mol) (at 3, 6, 9, 12 months follow-up)
•FPG (baseline, 3, 6, 9 and 12 months follow-up)
•Change in FPG (at 3, 6, 9 and 12 months follow-up)
•Peak and AUC glucose in MMTT (at baseline and 6 months follow-up)
•Gut hormones in MMTT (at baseline and 6 months follow-up)
•Pancreatic hormones in MMTT (at baseline and 6 months follow-up)
•Metabolic profile from MMTT (at baseline and 6 months follow-up)
•HOMA IR (at baseline and 6 months follow-up)
•Insulin sensitivity (at baseline and 6 months follow-up)
•Beta cell function (at baseline and 6 months follow-up)
•Liver fat fraction (at baseline and 6 months follow-up)
•Cardiac function (at baseline and 6 months follow-up)
•ALT and AST (at baseline, 3, 6 and 12 months follow-up)
•Change in AST and ALT (at 3, 6 and 12 months follow-up)
•Fibrosis-4 (FIB-4) score (at DMR and 3 months follow-up)
•Change in FIB-4 score (at 3 months follow-up)
•Urine microalbumin (at screening, baseline, 3, 6, 9 and 12 months follow-up)
•Blood pressure (at baseline and 6 months follow-up)
•DEXA body scan (at baseline and 6 months follow-up)
- Timepoints7 visits to the Academic Medical Center, 5 telephone consultations

Visit 1: Screening to assess subject eligibility
Visit 2: Baseline visit (< 3 weeks after visit 1)
Visit 3: DMR procedure (<3 weeks after visit 2)
Visit 4: 3 months follow-up post-DMR
5 telephone consultations
Visit 5: 6 months follow-up post-DMR
Visit 6: 9 months follow-up post-DMR
Visit 7: 12 months follow-up post-DMR
- Trial web sitehttps://www.amc.nl/web/Zorg/Patient/Meedoen-aan-onderzoek/Per-specialisme/Maag-Darm-Leverziekten.htm
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. P. Smeele
- CONTACT for SCIENTIFIC QUERIESProf. dr. J.J.G.H.M. Bergman
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
FRACTYL LABORATORIES INC. 17 Hartwell Avenue, Lexington, MA USA
- Publications-
- Brief summaryThe objective of this pilot study is to evaluate the effect of the Duodenal Mucosal Resurfacing procedure combined with GLP-1 administration and lifestyle intervention in subjects with insulindependent type 2 diabetes and an adequate betacell reserve. The aimed effect is an adequate glucose regulation without the need of insuline therapy. Secondary effects include improved cardiovascular, hepatological and metabolic parameters.

Summary:
• Single site (Academic Medical Center), open label study
• No randomization
• Screening to assess subject eligibility
• Endoscopic DMR procedure
• After DMR:
o Discontinuation insulin
o Post-procedural diet for 2 weeks
o At 2 weeks after DMR start GLP-1
o GLP-1 continued in case of adequate glucose regulation
o GLP-1 discontinued and insulin reintroduced in case of inadequate glucose regulation
o Nutritional and lifestyle counseling
• Follow-up at 3, 6, 9 and 12 months post DMR procedure
• Duodenal mucosal biopsies and feces sample before DMR (visit 3) and during follow-up endoscopy at 3 months post DMR (visit 4)
• Additional assessments at baseline (visit 2) and 6 months follow-up (visit 5):
o MRI fat fraction liver and cardiac MRI
o Mixed meal tolerance test
o Universal eating monitor
o DEXA body scan
o Dinamap for blood pressure
- Main changes (audit trail)
- RECORD6-sep-2017 - 15-sep-2017


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