The Effect of Pharmacotherapy With GLP-1 and GIP/GLP-1 Analogs on Changes in Qualitative and Quantitative Parameters of the Diet as Well as Metabolic and Behavioral Parameters in Patients With Excess Body Weight

Medical University of Warsaw100 enrolled

Overview

The aim of this study is to comprehensively assess the early and long-term effects of GLP-1 and GIP/GLP-1 analogue medications on metabolic and behavioral parameters, with particular emphasis on qualitative and quantitative dietary changes in patients undergoing treatment for overweight and obesity. Participation in the study will involve four follow-up visits per year at the Clinic of Diabetology and Internal Medicine, Central Clinical Hospital, University Clinical Clinical Hospital, Medical University of Warsaw: before treatment initiation and after 3, 6, and 12 months. The analysis will focus not only on metabolic effects (weight loss, changes in body composition, and improved biochemical parameters), but also on nutritional and behavioral aspects, including diet, appetite regulation, risk of malnutrition and muscle loss, and the occurrence of adverse events. The study will allow for a multifaceted assessment of the impact of treatment with GLP-1 and GIP/GLP-1 analogues on patients with excess body weight.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

GLP-1 Nutrition

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-65 years, * Diagnosed obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) with comorbidities associated with excess body weight (including type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease), * Eligibility for treatment with GLP-1 or GIP/GLP-1 analogues, * Not taking GLP-1 and GIP/GLP-1 analogue medications for at least one year prior to study enrollment, * Ability to provide informed consent, * Informed consent to participate in the study. Exclusion Criteria: * Age under 18 or over 65 years, * Inability to qualify for treatment with GLP-1 and GIP/GLP-1 analogues, * Pregnancy or breastfeeding, * Diagnosed eating disorders, * Active cancer or gastrointestinal conditions that may affect the absorption or tolerance of treatment (e.g., inflammatory bowel disease, conditions after extensive gastrointestinal resections, conditions after bariatric surgery), * Inability to participate in regular follow-up visits, * Inability to provide informed consent, * Failure to provide informed consent to participate in the study.

Outcomes

Primary Outcomes

change in body weight

percentage change in body weight from baseline to the end of follow-up

Time frame: 12 months

Secondary Outcomes

Change in lean body mass

Change in lean body mass measured using the Tanita MC-980MA Plus segmental body composition analyzer. Reported in kilograms (kg).

Time frame: 12 months

Change in total fat mass

Change in total fat mass measured using the Tanita MC-980MA Plus segmental body composition analyzer (bioelectrical impedance analysis). Reported in kilograms (kg).

Time frame: 12 months

Change in percent body fat

Change in percent body fat measured using the Tanita MC-980MA Plus segmental body composition analyzer. Reported as percent of total body mass (%).

Time frame: 12 months

Change in HbA1c

Change in hemoglobin A1c measured in venous blood using standard laboratory HPLC assay. Reported as percent (%).

Time frame: 12 months

Change in fasting plasma glucose

Change in fasting plasma glucose measured using enzymatic laboratory assay. Reported in mmol/L (or mg/dL).

Time frame: 12 months

Change in fasting insulin concentration

Change in fasting insulin measured using immunoassay (e.g., ELISA/chemiluminescence). Reported in μU/mL.

Time frame: 12 months

Change in HOMA-IR

Change in insulin resistance calculated using HOMA-IR (fasting insulin × fasting glucose / 22.5).

Time frame: 12 months

Change in lipid profile

Change in total cholesterol, LDL-C, HDL-C, and triglycerides measured using standard serum laboratory assays. Reported in mmol/L (or mg/dL).

Time frame: 12 months

Change in liver enzymes and creatinine

Change in ALT, AST (U/L) and serum creatinine (µmol/L) measured using standard laboratory methods.

Time frame: 12 months

Change in daily energy intake

Change in average daily energy intake assessed from 3-day food records (2 weekdays + 1 weekend day), analyzed using a 3-day food diary

Time frame: 12 months

Change in diabetes treatment

Number and percentage of participants with changes in diabetes pharmacotherapy (dose modification, medication initiation/discontinuation, or class switch).

Time frame: 12 months

Change in antihypertensive treatment

Number and percentage of participants with changes in antihypertensive therapy (dose adjustment, medication initiation/discontinuation, or class switch).

Time frame: 12 months

Change in daily carbohydrate intake

Change in daily carbohydrate intake assessed using a 3-day weighed food record and analyzed with validated dietary software. Reported in grams/day and as percent of total energy intake.

Time frame: 12 months

Change in daily fat intake

Change in total fat intake assessed using a 3-day weighed food record. Reported in grams/day and percent of total energy intake.

Time frame: 12 months

Change in daily protein intake

Change in protein intake assessed using a 3-day weighed food record. Reported in grams/day and grams per kilogram of body weight.

Time frame: 12 months

Change in diet quality score (KomPAN)

Change in diet quality assessed using the validated KomPAN questionnaire (modified for 3-month frequency assessment). Reported as the KomPAN dietary index score, according to validated scoring rules.

Time frame: 12 months

Change in frequency of consumption of selected food groups

Change in the frequency of consumption of selected food groups assessed using the validated KomPAN food frequency questionnaire. Includes changes in consumption of: vegetables, fruit, whole grains, sweets, high-fat foods, meat products, sweetened beverages, and others defined in KomPAN. Reported as frequency categories or converted frequency units.

Time frame: 12 months

Change in emotional eating score (TFEQ-R18)

Change in emotional eating assessed with the validated Three-Factor Eating Questionnaire (TFEQ-R18). Scale range 0-100 (converted), higher scores indicate stronger emotional eating tendencies.

Time frame: 12 months

Change in uncontrolled eating score (TFEQ-R18)

Change in uncontrolled eating assessed using TFEQ-R18. Higher scores indicate greater susceptibility to uncontrolled eating.

Time frame: 12 months

Change in cognitive restraint score (TFEQ-R18)

Change in cognitive restraint (intentional food restriction) assessed using TFEQ-R18. Higher scores indicate higher restraint.

Time frame: 12 months

Change in subjective hunger (VAS)

Change in subjective hunger measured using a Visual Analog Scale (VAS, 0-100 mm) within the validated questionnaire set. Higher scores indicate greater hunger

Time frame: 12 months

Change in subjective satiety (VAS)

Change in subjective satiety measured using VAS (0-100 mm). Higher scores indicate greater satiety.

Time frame: 12 months

Change in sweet taste preference (VAS)

Change in desire to consume sweet foods measured using a Visual Analog Scale (VAS, 0-100 mm) as part of the custom taste preference questionnaire.

Time frame: 12 months

Change in preference for high-fat foods (VAS)

Change in desire to consume high-fat foods measured using VAS (0-100 mm).

Time frame: 12 months

Change in preference for salty foods (VAS)

Change in desire to consume salty foods measured using VAS (0-100 mm).

Time frame: 12 months

Change in preference for meat-based products (VAS)

Change in desire to consume meat-based foods measured using VAS (0-100 mm).

Time frame: 12 months

Change in preference for fresh/fruit-based foods (VAS)

Change in desire to consume fresh or fruit-based foods assessed using VAS (0-100 mm).

Time frame: 12 months

Change in risk of inadequate nutrient intake

Change in risk of insufficient intake of key nutrients (vitamin D, B12, folate, iron, protein) assessed indirectly through 3-day weighed food records and KomPAN questionnaire data. Reported as intake relative to recommended dietary allowances.

Time frame: 12 months

Change in meal frequency

Change in number of daily eating occasions based on the 3-day food record. Reported as meals/day.

Time frame: 12 months

Change in mean daily step count

Change in average daily number of steps recorded from the participant's smartphone health application. Step count is extracted from the app's built-in accelerometer-based activity tracking. Reported as steps per day.

Time frame: 12 months

Change in handgrip strength

Change in maximal handgrip strength measured using a calibrated handheld dynamometer. Strength is assessed in the dominant hand, with three attempts per measurement, and the highest value recorded. Reported in kilograms (kg).

Time frame: 12 months

The Effect of Pharmacotherapy With GLP-1 and GIP/GLP-1 Analogs on Changes in Qualitative and Quantitative Parameters of the Diet as Well as Metabolic and Behavioral Parameters in Patients With Excess Body Weight

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts