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aRYGB for Obesity (CLIMB II Trial)
N/A
Recruiting
Led By Salvador Navarrete, MD
Research Sponsored by Salvador Navarrete
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6,12,24 and 60 months from surgery
Awards & highlights
CLIMB II Trial Summary
"This trial will compare two different techniques for weight loss surgery. One technique uses fixed lengths for certain parts of the surgery, while the other adjusts the lengths based on the patient's small bowel length. The
Who is the study for?
This trial is for individuals with obesity, specifically those who are candidates for Roux-en-Y Gastric Bypass (RYGB) surgery. Participants should be willing to undergo a surgical procedure where the lengths of certain parts of their small bowel will be adjusted based on their total small bowel length.Check my eligibility
What is being tested?
The study is testing if adjusting the limb lengths in RYGB surgery to match individual patient's anatomy leads to better weight loss and health outcomes compared to using standard fixed limb lengths. Patients will be randomly assigned to receive either the adjusted or standard surgery.See study design
What are the potential side effects?
Potential side effects from RYGB surgery can include nutritional deficiencies, digestive issues such as nausea and vomiting, abdominal pain, and complications related to the surgical procedure itself.
CLIMB II Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6,12,24 and 60 months from surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6,12,24 and 60 months from surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine change in TWL after aRYGB compared to sRYGB in morbidly obese patients
Secondary outcome measures
To compare rates of DM resolution between aRYGB Vs sRYGB by DM subgroup analysis
To investigate postoperative efficacy rates of aRYGB compared to sRYGB on alleviating metabolic syndrome in morbid obesity
To investigate the presence of postoperative vitamin and nutritional deficiencies between the groups.
Side effects data
From 2023 Phase 3 trial • 521 Patients • NCT0410906665%
Alopecia
48%
Nausea
36%
Anaemia
26%
Fatigue
25%
Aspartate aminotransferase increased
24%
Diarrhoea
21%
Alanine aminotransferase increased
20%
Vomiting
20%
Asthenia
19%
Headache
19%
Neuropathy peripheral
19%
Neutropenia
17%
Constipation
16%
COVID-19
16%
Neutrophil count decreased
15%
Arthralgia
14%
Rash
13%
Decreased appetite
13%
Hypothyroidism
12%
Hyperglycaemia
12%
White blood cell count decreased
12%
Radiation skin injury
11%
Lymphopenia
11%
Myalgia
9%
Pruritus
9%
Infusion related reaction
9%
Cough
9%
Pyrexia
9%
Urinary tract infection
9%
Epistaxis
9%
Hypertension
8%
Blood alkaline phosphatase increased
7%
Dizziness
7%
Dyspepsia
7%
Dysgeusia
7%
Hot flush
6%
Peripheral sensory neuropathy
6%
Paraesthesia
6%
Abdominal pain upper
6%
Back pain
6%
Pain in extremity
6%
Illness
6%
Mucosal inflammation
6%
Leukopenia
6%
Hypersensitivity
6%
Hyperthyroidism
6%
Insomnia
5%
Anxiety
5%
Weight decreased
5%
Blood lactate dehydrogenase increased
5%
Folliculitis
4%
Abdominal pain
4%
Blood thyroid stimulating hormone increased
4%
Dry mouth
4%
Adrenal insufficiency
4%
Oedema peripheral
4%
Pain
3%
Blood thyroid stimulating hormone decreased
3%
Dyspnoea
3%
Hyponatraemia
3%
Stomatitis
3%
Dry eye
3%
Lacrimation increased
3%
Gastrooesophageal reflux disease
3%
Nasopharyngitis
3%
Lymphocyte count decreased
3%
Hypokalaemia
2%
Nail disorder
2%
Pulmonary embolism
2%
Rash maculo-papular
2%
Postoperative wound infection
2%
Bone pain
2%
Breast pain
2%
Thrombocytopenia
2%
Depression
2%
Palpitations
2%
Dry skin
2%
Onycholysis
2%
Malignant neoplasm progression
2%
Febrile neutropenia
2%
COVID-19 pneumonia
2%
Tachycardia
2%
Procedural pain
2%
Oropharyngeal pain
1%
Left ventricular failure
1%
Thyroiditis subacute
1%
Interstitial lung disease
1%
Upper respiratory tract infection
1%
Cervix carcinoma
1%
Embolism
1%
Cardiac perfusion defect
1%
Pneumonia bacterial
1%
Cardiac failure
1%
Vertigo
1%
Myocarditis
1%
Pemphigoid
1%
Immune-mediated adrenal insufficiency
1%
Hypotension
1%
Chills
1%
Pneumonia
1%
Myelosuppression
1%
Intracranial pressure increased
1%
Cardio-respiratory arrest
1%
Myocardial infarction
1%
Colitis
1%
Anaphylactic reaction
1%
Diabetic ketoacidosis
1%
Hepatitis cholestatic
1%
Infection
1%
Glomerulonephritis
1%
Arterial thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Nivo + Chemo (PTX QW + AC Q3W) / Nivo + ET
Arm A: Nivo + Chemo (PTX QW + AC Q2W) / Nivo + ET
Arm B: Nivo Placebo + Chemo (PTX QW + AC Q3W) / ET
Arm B: Nivo Placebo + Chemo (PTX QW + AC Q2W) / ET
CLIMB II Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: aRYGBExperimental Treatment1 Intervention
BP and roux limb lengths measuring 30% and 15% respectively of patient's total small bowel length.
Group II: sRYGBActive Control1 Intervention
Standard fixed-length RYGB
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgery
2000
Completed Phase 3
~2550
Find a Location
Who is running the clinical trial?
Salvador NavarreteLead Sponsor
Salvador Navarrete, MDPrincipal InvestigatorThe Cleveland Clinic
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current number of participants being recruited for this research study?
"Indeed, as per clinicaltrials.gov, this trial is actively seeking candidates. Commencing on 1/12/2024 and last revised on 2/27/2024, the study aims to enroll 262 participants from a single location."
Answered by AI
Is the clinical trial open to participants younger than 65 years old?
"To be eligible for this research, participants must be at least 18 years of age and no older than 70."
Answered by AI
Is this medical study currently open to new participants seeking treatment?
"Affirmative. Data from clinicaltrials.gov indicates that this study is presently seeking participants, with initial posting on January 12th, 2024 and the latest update on February 27th, 2024. The trial aims to recruit a total of 262 patients at one designated site."
Answered by AI
Which individuals meet the criteria for participating in this medical study?
"To be eligible for this research study, individuals should possess obesity and fall within the age range of 18 to 70 years old. Approximately 262 participants are being sought for enrollment in the clinical trial."
Answered by AI
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