Clinical trial NCT04230655: Weight Loss in Adults With Obesity Using a Combination of Low Energy Diet, Group Treatment and Intragastric Balloon
Official title: The Effects of a Low Energy Diet Versus Low Energy Diet and Intragastric Balloon in Adults With Obesity, All in Combination With Group Treatment: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Weight Loss
Non-Alcoholic Fatty Liver Disease
Keywords: Obesity
Weight loss
Low energy diet
Intragastric balloon
Group treatment
Non-alcoholic fatty liver disease
Quality of life
Body weight
Glucose metabolism
Eating behavior
Microbiomics
Physical activity
Gastrointestinal symptoms
Psychological parameters
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 110
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design is an open labelled, randomized, controlled clinical trial, with a ratio 1:1.
Primary purpose: TREATMENT

Brief summary: In Sweden, approximately 1.3 million adults have obesity. Obesity decreases quality of life (QoL) and increases the risk of diseases such as type 2-diabetes, non-alcoholic fatty liver disease (NAFLD), cancer and cardiovascular diseases. Consequently, weight loss improves QoL and decreases the risk for obesity-related comorbidities.

A treatment combination using a low energy diet (LED) and group treatment based on cognitive behavioral therapy (CBT), leads to 18 percent weight loss after 6 months. Six months treatment with an intragastric balloon (IGB) leads to 13 percent weight loss. However, both treatments are usually followed by weight regain. Combining these treatments has not been studied before but could lead to better weight maintenance.

The hypothesis is that treatment of adults with obesity, with LED, CBT and IGB, leads to greater weight loss after 1 year compared to treatment with LED and CBT only.

The study is a randomized, controlled clinical trial, with a 2-year follow-up. One hundred and ten adults, age 30-65 years, with a BMI of 30-45 kg/m\^2 will be included. All participants will receive 6 months of LED, followed by randomization to either 6 months with IGB or a control group without IGB. All participants receive CBT-based group treatment during 12 months and followed up after 2 years.

If the treatment combination of LED, CBT and IGB leads to significant weight loss and improved weight maintenance, increased QoL and reductions of comorbidities and costs of health care are expected. Effects of treatment on eating behavior, NAFLD, physical activity, psychological parameters, the gut microbiota, gut permeability and metabolomics will be assessed.


Eligibility criteria: Inclusion Criteria:

* BMI ≥ 30 and ≤45 kg/m\^2
* Age 30 to 65 years

Exclusion Criteria:

* Participation in an organized weight reduction programme or pharmacological treatment for weight loss within the last 3 months
* Daily use of meal replacement products within the last 3 months
* Previous gastric surgery
* Current gastric, duodenal or oesophageal ulcers
* Inflammatory disease of the gastrointestinal tract including oesophagitis, or specific inflammation such as Crohn's disease
* Known potential upper gastrointestinal bleeding conditions such as gastric or oesophageal varices
* Known structural abnormalities of the pharynx or oesophagus
* Symptoms suggestive for severe gastric motility disorder
* Known hiatus hernia ≥ 5 cm
* Cancer diagnosed within the last 5 years or ongoing treatment for cancer (except non-metastasising skin cancer)
* Known severe heart failure (NYHA 3-4)
* Known chronic obstructive pulmonary disease (FEV1 ≤ 50 percent)
* Kidney failure (eGFR ≤ 30 ml/min)
* Liver failure (liver enzymes more than 3 times the normal threshold)
* Known proliferative retinopathy
* Known or suspected abuse of alcohol or narcotics
* Current or history of systemic treatment with corticosteroids within the last 3 months
* Known myocardial infarction or stroke within the last 6 months
* Current or history of pancreatitis
* Pregnancy, intention to become pregnant or breastfeeding during the study
* Untreated or insufficient treated hypo- or hyperthyroidism
* Current use of anticoagulants: warfarin, apixaban, dabigatran, edoxaban and rivaroxaban
* Current use of thrombocyte aggregation inhibitors: clopidogrel and acetylsalicylic acid
* Known or previous eating disorder
* Antimicrobial treatment within 3 months prior to study may lead to postponed participation
* Regular consumption of probiotic capsules within 1 month prior to study start may lead to postponed participation
* Participants considered to be unsuitable for the study by the investigator (e.g. serious psychiatric disorders, suspected eating disorders)

Primary outcomes:
measure: Weight loss in percent of total body weight
timeFrame: Change from baseline at 12 months
Secondary outcomes:
measure: Weight loss in percent of total body weight
timeFrame: Change from baseline at 6 months
measure: Weight loss in percent of total body weight at 2-year follow-up
timeFrame: Change from baseline at 24 months
measure: The proportion of participants with ≥5 percent reduction of total body weight from baseline
timeFrame: 6, 12 and 24 months
measure: The proportion of participants with ≥10 percent reduction of total body weight from baseline
timeFrame: 6, 12 and 24 months
measure: The proportion of participants with ≥15 percent reduction of total body weight from baseline
timeFrame: 6, 12 and 24 months
measure: Effect of treatment on bioelectrical impedance measurement to assess fat mass
timeFrame: Change from baseline at 6, 12 and 24 months
measure: Effect of treatment on bioelectrical impedance measurement to assess muscle mass
timeFrame: Change from baseline at 6, 12 and 24 months
measure: Change in waist circumference
timeFrame: Change from baseline at 6, 12 and 24 months
measure: Change in 2-hour oral glucose tolerance test
timeFrame: Change from baseline at 6 and 12 months
measure: Change in Hemoglobin A1c
timeFrame: Change from baseline at 6 and 12 months
measure: Change in serum lipids
timeFrame: Change from baseline at 6 and 12 months
measure: Change in insulin
timeFrame: Change from baseline at 6 and 12 months
measure: Change in Homeostatic Model Assessment of Insulin Resistance
timeFrame: Change from baseline at 6 and 12 months
measure: Change in kidney function
timeFrame: Change from baseline at 6 and 12 months
measure: Change in liver transaminases
timeFrame: Change from baseline at 6 and 12 months
measure: Change in thrombocytes
timeFrame: Change from baseline at 6 and 12 months
measure: Change in blood pressure
timeFrame: Change from baseline at 6 and 12 months
measure: Effect of treatment on vibration-controlled transient elastography measurement to assess level of liver steatosis and fibrosis
timeFrame: Change from baseline at 6 and 12 months
measure: Effect of treatment on RAND-36 (SF-36) to measure QoL
timeFrame: Change from baseline at 6, 12 and 24 months
measure: Effect of treatment on the Obesity-related Problems scale, version 3 (OPv3) to measure weight-related psychosocial functioning
timeFrame: Change from baseline at 4, 12, 20, 24, 28, 36, 44, 52 and 104 weeks
measure: Effects of treatment on the Three-Factor Eating Questionnaire-Revised 18 (TFEQ-R18V2) items to measure eating behavior
timeFrame: Change from baseline at 4, 12, 20, 24, 28, 36, 44, 52 and 104 weeks
measure: Effects of treatment on hunger and satiety
timeFrame: Change from baseline at 4, 12, 20, 24, 28, 36, 44, 52 and 104 weeks
measure: Effect of treatment on 7-day step count to measure physical activity
timeFrame: Change from baseline at 6, 12 and 24 months
measure: Effect of treatment on sitting time and physical activity
timeFrame: Change from baseline at 6, 12 and 24 months
measure: Effect of treatment on the use of medication for glucose lowering treatment, hypertension and hyperlipidemia
timeFrame: Change from baseline at 6, 12 and 24 months
measure: The effect of treatment on the use of health care and absence from work during treatment
timeFrame: Change from baseline at 6, 12 and 24 months
measure: Calculation of cost-effectiveness of treatment using multi-variable analysis
timeFrame: Change from baseline at 6, 12 and 24 months
Other outcomes:
measure: Comparison of the calculated risk for liver fibrosis using the fibrosis-4 (FIB-4) calculation to prevalence of liver fibrosis in the study population detected by vibration-controlled transient elastography
timeFrame: At baseline, 6 and 12
measure: Effect of treatment on lipidomics
timeFrame: Change from baseline at 6 and 12 months
measure: Change in gut microbiota compositions during treatment with LED, re-introduction of the recommended diet and treatment with IGB
timeFrame: Change from baseline at 2, 4, 6, 9 and 12 months
measure: Food frequency questionnaires to evaluate change in dietary intake
timeFrame: Change from baseline, 6 and 12 months
measure: The Bristol Stool Form Scale is used to asses stool form
timeFrame: Change from baseline at 2, 4, 6, 9 and 12 months
measure: Change in Glucagon-like peptide-1
timeFrame: Change from baseline at 6 and 12 months
measure: Change in Glucagon-like peptide-2
timeFrame: Change from baseline at 6 and 12 months
measure: Change in peptide YY
timeFrame: Change from baseline at 6 and 12 months
measure: Change in leptin
timeFrame: Change from baseline at 6 and 12 months
measure: Change in ghrelin
timeFrame: Change from baseline at 6 and 12 months
measure: Change in pro-insulin
timeFrame: Change from baseline at 6 and 12 months
measure: Change in C-peptide
timeFrame: Change from baseline at 6 and 12 months
measure: Change in glucagon
timeFrame: Change from baseline at 6 and 12 months
measure: Change in adiponectin
timeFrame: Change from baseline at 6 and 12 months
measure: Change in glycerol
timeFrame: Change from baseline at 6 and 12 months
measure: Change in free fatty acid
timeFrame: Change from baseline at 6 and 12 months
measure: Effect of treatment on highly sensitive C-reactive protein
timeFrame: Change from baseline at 6 and 12 months
measure: Effect of treatment on Interleukin-6
timeFrame: Change from baseline at 6 and 12 months
measure: Effect of treatment on Tumor Necrosis Factor-alfa
timeFrame: Change from baseline at 6 and 12 months
measure: Effect of treatment on Plasminogen Activator Inhibitor-1
timeFrame: Change from baseline at 6 and 12 months
measure: Effect of treatment on metabolomics
timeFrame: Change from baseline at 6 and 12 months
measure: Effect of treatment on Zonulin
timeFrame: Change from baseline at 6 and 12 months
measure: Gastrointestinal Symptom Rating Scale to assess gastrointestinal symptoms
timeFrame: Baseline, 4, 12, 20, 24, 28, 36, 44 and 52 weeks
measure: Visceral Sensitivity Index to assess fear of gastrointestinal symptoms
timeFrame: Baseline, 4, 12, 20, 24, 28, 36, 44 and 52 weeks
measure: Nepean Dyspepsia Index to assess dyspepsia
timeFrame: Baseline, 4, 12, 20, 24, 28, 36, 44 and 52 weeks
measure: Rome IV criteria to assess symptoms for irritable bowel syndrome
timeFrame: Baseline, 6 and 12 months
measure: 13C Spirulina Breath test to assess gastric emptying rate in participants randomized to IGB treatment
timeFrame: 1 to 28 days before IGB placement
measure: Analysis of number and causes of early extractions of the gastric balloon to asses tolerability of IGB treatment
timeFrame: 24, 28, 36, 44 and 52 weeks
measure: Change in Depression Module (PHQ-9) questionnaire
timeFrame: Change from baseline at 4, 12, 20, 24, 28, 36, 44 and 52 weeks
measure: Change in Anxiety module (GAD-7) questionnaire
timeFrame: Change from baseline at 4, 12, 20, 24, 28, 36, 44 and 52 weeks
measure: Change in Somatic symptom severity ('somatization') module (PHQ-15) questionnaire
timeFrame: Change from baseline at 6 and 12 months
measure: Pittsburgh Sleep Quality Index to assess sleep quality
timeFrame: Change from baseline at 4, 12, 20, 24, 28, 36, 44 and 52 weeks
measure: Acceptance and Action Questionnaire for Weight-Related Difficulties
timeFrame: Change from baseline at 4, 12, 20, 24, 28, 36, 44 and 52 weeks
Locations:
city: Örebro
country: Sweden
facility: Medicinmottagning 5/Överviktsenheten, University Hospital Örebro
Study officials:
affiliation: johan.jendle@oru.se
name: Johan Jendle, Professor
role: PRINCIPAL_INVESTIGATOR
References: