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Although type 1 diabetes (T1D) has traditionally been considered a disease associated with a lean phenotype, it is estimated that up to 2 out of 3 people living with T1D are overweight or obese, factors linked to an increased risk of complications in these patients. The available evidence regarding nutritional strategies for weight loss in T1D is very limited, and clinical trials are needed to determine how to effectively and safely promote weight loss in this population. In recent years, low-carbohydrate diets and several intermittent fasting protocols have demonstrated efficacy in promoting weight loss both in patients with type 2 diabetes and in patients with obesity without diabetes. In this study, we will evaluate the efficacy of moderate carbohydrate restriction, time-restricted eating, and standard calorie restriction for weight loss in adults with T1D and overweight/obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate carbohydrate restriction | Experimental | Moderate carbohydrate restriction (25-30% of total energy intake) plus 25% caloric restriction. Eating window ≥12 hours. |
|
| Time-restricted eating | Experimental | 8-hour early eating window (starting no later than 10 a.m.) plus 25% caloric restriction |
|
| Standard calorie restriction | Active Comparator | 25% caloric restriction. Eating window ≥12 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate carbohydrate restriction | Behavioral | Participants will follow a diet with moderate carbohydrate restriction (25-30%), together with 25% caloric restriction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in percent body weight | Measured by a calibrated digital scale | From baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycated hemoglobin | Fasting blood samples. Glycated hemoglobin will be assessed by HPLC | From baseline to 6 months |
| Change in continuous glucose monitoring (CGM) parameters | Parameters measured by CGM, including time in range, time below range, mean glucose, standard deviation of glucose, coefficient of variation of glucose, time above range, time in tight range, glucose management indicator |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gut microbiota | Gut microbiota composition and diversity, assessed by 16S rRNA | From baseline to 6 months |
| Change in DNA methylation | Measured by methylation array (Illumina) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| José Ignacio Martínez-Montoro, MD, PhD | Contact | +34 951032647 | martinezmontoro@ibima.eu |
| Name | Affiliation | Role |
|---|---|---|
| José Ignacio Martínez-Montoro, MD, PhD | Virgen de la Victoria University Hospital, Málaga, Spain | Principal Investigator |
| Francisco J Tinahones, MD, PhD | Virgen de la Victoria University Hospital, Málaga, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virgen de la Victoria University Hospital | Málaga | Málaga | 29010 | Spain |
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Outcome assessors and data analysts will be blinded to treatment allocation
| Early time-restricted eating | Behavioral | Participants will follow a standard diet with an 8-hour early eating window, starting no later than 10 a.m. (16-hour fast), together with 25% caloric restriction |
|
| Standard calorie restriction | Behavioral | Participants will follow a standard diet with 25% caloric restriction |
|
| From baseline to 6 months |
| Change in absolute body weight (kg) | Measured by a calibrated digital scale | From baseline to 6 months |
| Change in body mass index (BMI) | Calculated as kg/m2 | From baseline to 6 months |
| Change in anthropometric parameters | Assessed by standard methods (waist circumference, hip circumference, waist-to-hip-ratio) | From baseline to 6 months |
| Change in body composition (fat mass, fat-free mass) | Assessed by air displacement plethysmography | From baseline to 6 months |
| Change in systolic and diastolic blood pressure | Measured by standard procedures | From baseline to 6 months |
| Change in insulin dose | Assessed by the recording of basal insulin dose, bolus insulin dose, total insulin dose (IU/day, IU/kg/day) | From baseline to 6 months |
| Change in lipid profile | Fasting blood samples, including several lipid parameters (e.g., total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides) | From baseline to 6 months |
| Change in hepatic profile | Fasting blood samples including several liver parameters (e.g., aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase) | From baseline to 6 months |
| Change in estimated glucose disposal rate (eGDR) | Insulin resistance will be calculated from waist circumference, hypertension status, and HbA1c | From baseline to 6 months |
| Change in eating behavior | Assessed by the Three-Factor Eating Questionnaire - Revised 18 items (TEFQ-18) | From baseline to 6 months |
| Change in T1D-related distress | Assessed by the Type1 Diabetes Distress Assessment System (T1-DDAS) | From baseline to 6 months |
| Change in treatment satisfaction | Assessed by the Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs) and change version (DTSQc) | From baseline to 6 months |
| Change in quality of life and general health | Assessed by the EuroQol 5 dimensions 5 levels (EQ-5D-5L) | From baseline to 6 months |
| Change in sleep quality | Assessed by the Pittsburgh Sleep Quality Index (PSQI) and by accelorometry | From baseline to 6 months |
| Change in ketonemia | Measured by capillary blood β-hydroxybutyrate | From baseline to 6 months |
| Change in physical activity | Assessed by the International Physical Activity Questionnaire and by accelorometry | From baseline to 6 months |
| Adverse events | Assessed by systematic recording of adverse events throughout the study period | From baseline to 6 months |
| Change in resting energy expenditure | Assessed by indirect calorimetry | From baseline to 6 months |
| Change in energy and nutrient intake | Assessed by 24 h recalls | From baseline to 6 months |
| Dietary adherence | Assessed by 24 h recalls and adherence logs | From baseline to 6 months |
| From baseline to 6 months |
| Change in inflammatory parameters | Fasting blood samples, including several parameters (e.g., C-reactive protein, interleukin 6, interleukin IL-10, interleukin-1β, TNF-alpha) | From baseline to 6 months |
| Change in adipokines and gastrointestinal hormones | Fasting blood samples, including several parameters (e.g., leptin, adiponectin, GLP-1, GIP) | From baseline to 6 months |
| Change in other cardiometabolic and renal biomarkers | Fasting blood samples, including several parameters (e.g., apolipoprotein profile, homocysteine, N-terminal pro-B-type natriuretic peptide) and urinary albumin-to-creatinine ratio | From baseline to 6 months |
| Change in phase angle | Assessed by bioelectrical impedance analysis | From baseline to 6 months |
| Change in ultrasound-assessed muscle and adipose tissue measurements (nutritional ultrasound) | Assessed by ultrasound measurement of the rectus femoris muscle of the quadriceps, superficial and deep subcutaneous adipose tissue layers, and visceral adipose tissue | From baseline to 6 months |
| Change in vibration-controlled transient elastography (VCTE) parameters | Assessed by liver stiffness measurement (LSM) and controlled attenuation parameter (CAP) | From baseline to 6 months |
| Change in sexual function | Assessed by the International Index of Erectile Function (IIEF) for men and Female Sexual Function Measure (FSM-2) for women | From baseline to 6 months |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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