Metabolic Effects of Duodenal Jejunal Bypass Liner for Type 2 Diabetes Mellitus

NCT02800668 | Completed

• 1 other identifier: DJBL-HDZ
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Implantation of a duodenal-jejunal endoluminal bypass liner (DJBL) has shown to induce weight loss and to improve metabolic parameters. DJBL is a reversible endoduodenal sleeve mimicking biliodigestive digestion while lacking risks and limitations of bariatric surgery. Effects on metabolic control, body mass parameters, appetite regulation, glucose tolerance, organ health, and lipid profile were determined in 16 morbidly overweight patients with type 2 diabetes mellitus. In addition, relevant hormones (Leptin, ghrelin, gastric inhibitory peptide, glucagon-like peptide 1, and insulin) were measured by enzyme-linked immunosorbent assay (ELISA) and chemiluminescent microparticle immunoassay (CMIA) at 0, 1 and 32, and 52 weeks post-implant following a mixed meal tolerance test, which was applied for diagnostic purposes only.

Conditions

Type 2 Diabetes Mellitus; Obesity

Keywords

Duodenal Jejunal Bypass Liner; obesity; weight loss therapy

Outcome Measures

Primary Outcomes (1)

• weight loss in kg

  weight loss defined as excess weight loss

  12 months

Secondary Outcomes (13)

• Change in body fat in %, measured via bioimpedance scaling

  12 months

• Change in HbA1c in mmol/mol

  12 months

• Change in LDL-cholesterol in mg/dl

  12 months

• Change in triglycerides in mg/dl

  12 months

• Change in liver enzyme aspartate aminotransferase (ASAT) in U/l

  12 months

Study Arms (1)

DJBL implant-group

T2DM Patients implanted with a DJBL (Duodenal jejunal Bypass liner, EndoBarrier, GI Dynamics) due to medical reasons. The subjects were regular in-patients of the Diabetes Center at the Heart and Diabetes Center NRW, Germany and gave informed consent for related procedures and data handling. The subjects had BMI ≥35 kg/m2, T2DM, and a history of frustrated weight loss attempts. Exclusion criteria: history of gastric surgery, gastric or duodenal ulcers, thyroid disorders, gastrointestinal disorders with intestinal resorption dysfunction, therapy with oral anticoagulants, use of acetyl salicylic acid or non-steroidal anti-inflammatory drugs, drug abuse (incl. alcohol), symptomatic cardiovascular disease, renal insufficiency (GFR \<50 ml/min), pregnancy or breast feeding.

Device: DJBL (Duodenal jejunal bypass liner, EndoBarrier)

Interventions

DJBL (Duodenal jejunal bypass liner, EndoBarrier) DEVICE

Implantation of EndoBarrier after medical and patient's decision, Duration of treatment 12 months in maximum, follow up for 4 weeks after Explantation, follow up during treatment by physical examination, ECG control, sampling and analysis of blood parameters, mixed meal tolerance tests only for diagnostic purposes to assess gut hormonal changes and metabolic parameters

Also known as: EndoBarrier

DJBL implant-group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects were regular inpatients with type 2 Diabetes mellitus of the Diabetes Center at the Heart and Diabetes Center NRW, Germany and gave informed consent for related procedures and data handling

You may qualify if:

• T2DM
• body mass index (BMI) ≥35 kg/m2
• history of frustrated weight loss attempts

You may not qualify if:

• history of gastric surgery, gastric or duodenal ulcers
• thyroid disorders
• gastrointestinal disorders associated with intestinal resorption dysfunction
• therapy with oral anticoagulants like marcumar
• use of acetyl salicylic acid or non-steroidal anti-inflammatory drugs
• drug abuse (incl. alcohol)
• symptomatic cardiovascular disease including heart failure New York Heart Association IV
• renal insufficiency defined as GFR \<50 ml/min
• pregnancy or breast feeding

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Herz- und Diabeteszentrum

Bad Oeynhausen, 32545, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sampling during study, analysis via ELISA for special markers at study end in one batch, active medical control parameters like HbA1c, cholesterol, hemogram etc. at visits

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Diethelm Tschoepe, Prof MD

  Herz und Diabeteszentrum NRW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr.

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 15, 2016
• Study Start: October 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)