An interventional study of Moderate carbohydrate restriction and Early time-restricted eating in Type 1 Diabetes (T1D) and Obesity & Overweight, sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Not applicable, Interventional, and Treatment
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. This study 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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 75 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud is the lead sponsor of 71 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Moderate carbohydrate restriction (25-30% of total energy intake) plus 25% caloric restriction. Eating window ≥12 hours.
Behavioral: Moderate carbohydrate restriction
8-hour early eating window (starting no later than 10 a.m.) plus 25% caloric restriction
Behavioral: Early time-restricted eating
25% caloric restriction. Eating window ≥12 hours.
Behavioral: Standard calorie restriction
Participants will follow a diet with moderate carbohydrate restriction (25-30%), together with 25% caloric restriction
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
Participants will follow a standard diet with 25% caloric restriction
Change in percent body weight
Measured by a calibrated digital scale
Time frame: From baseline to 6 months
Change in glycated hemoglobin
Fasting blood samples. Glycated hemoglobin will be assessed by HPLC
Time frame: 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
Time frame: From baseline to 6 months
Change in absolute body weight (kg)
Measured by a calibrated digital scale
Time frame: From baseline to 6 months
Change in body mass index (BMI)
Calculated as kg/m2
Time frame: From baseline to 6 months
Change in anthropometric parameters
Assessed by standard methods (waist circumference, hip circumference, waist-to-hip-ratio)
Time frame: From baseline to 6 months
Change in body composition (fat mass, fat-free mass)
Assessed by air displacement plethysmography
Time frame: From baseline to 6 months
Change in systolic and diastolic blood pressure
Measured by standard procedures
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: From baseline to 6 months
Change in estimated glucose disposal rate (eGDR)
Insulin resistance will be calculated from waist circumference, hypertension status, and HbA1c
Time frame: From baseline to 6 months
Change in eating behavior
Assessed by the Three-Factor Eating Questionnaire - Revised 18 items (TEFQ-18)
Time frame: From baseline to 6 months
Change in T1D-related distress
Assessed by the Type1 Diabetes Distress Assessment System (T1-DDAS)
Time frame: From baseline to 6 months
Change in treatment satisfaction
Assessed by the Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs) and change version (DTSQc)
Time frame: From baseline to 6 months
Change in quality of life and general health
Assessed by the EuroQol 5 dimensions 5 levels (EQ-5D-5L)
Time frame: From baseline to 6 months
Change in sleep quality
Assessed by the Pittsburgh Sleep Quality Index (PSQI) and by accelorometry
Time frame: From baseline to 6 months
Change in ketonemia
Measured by capillary blood β-hydroxybutyrate
Time frame: From baseline to 6 months
Change in physical activity
Assessed by the International Physical Activity Questionnaire and by accelorometry
Time frame: From baseline to 6 months
Adverse events
Assessed by systematic recording of adverse events throughout the study period
Time frame: From baseline to 6 months
Change in resting energy expenditure
Assessed by indirect calorimetry
Time frame: From baseline to 6 months
Change in energy and nutrient intake
Assessed by 24 h recalls
Time frame: From baseline to 6 months
Dietary adherence
Assessed by 24 h recalls and adherence logs
Time frame: From baseline to 6 months
Change in gut microbiota
Gut microbiota composition and diversity, assessed by 16S rRNA
Time frame: From baseline to 6 months
Change in DNA methylation
Measured by methylation array (Illumina)
Time frame: 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)
Time frame: From baseline to 6 months
Change in adipokines and gastrointestinal hormones
Fasting blood samples, including several parameters (e.g., leptin, adiponectin, GLP-1, GIP)
Time frame: 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
Time frame: From baseline to 6 months
Change in phase angle
Assessed by bioelectrical impedance analysis
Time frame: 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
Time frame: From baseline to 6 months
Change in vibration-controlled transient elastography (VCTE) parameters
Assessed by liver stiffness measurement (LSM) and controlled attenuation parameter (CAP)
Time frame: 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
Time frame: From baseline to 6 months
Plan to share: No
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Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud