Type 2 Diabetes
Conditions
Brief summary
Obesity is considered the largest chronic non-communicable disease (globesity) worldwide with a growing trend in the near future. Weight loss programs are strongly recommended in obese patients, especially with type 1 diabetes mellitus (T2DM), although the majority of subjects do not reach or maintain the recommended weight loss target with nutritional intervention alone and one-third of those who achieve a significant weight loss returns to original body weight within one year. Metarecod® (Neopolicaptil Gel Retard) is a substance based medical device consisting of a macromolecule complex derived from high-fiber raw materials, whose mode of action consists in creating an endoluminal gel in the gut that limits glucose and lipids absorption. The primary aim of the present study is to assess whether the combination of Metarecod® and standard diet as compared to diet alone can achieve a superior weight loss over 12 months of treatment. The present study will also compare the effects of the combination of Metarecod® and diet vs diet alone on: 1. the improvement of glycemic variability and metabolic indexes; 2. the oxidative status, the endothelial anti-thrombotic activity, the inflammatory status; 3. the induction of favorable changes in gut microbiota composition and intestinal permeability.
Interventions
DIETARY_SUPPLEMENTMetarecod
Policaptil Gel Retard: Metarecod®. The medical device will be given as 1 sachet twice daily
OTHERDiet
Diet program will be planned to achieve a ≥8% body weight relative reduction over 12 months and tailored calculating a 20% caloric relative decrease from habitual energy intake, corresponding to an average energy deficit of approximately 500 kcal/daily (approximately a total of 1,200-1,500/daily Kcal for women and 1,500-1,800/daily Kcal for men), with \<30% of total calories from fat (\<10% from satured fats) and at least 15% of total calories from proteins. For carbohydrate intake, low glycemic index food will be preferred to high glycemic index food, to prevent higher post prandial glycemic excursions
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Signed Informed consent at study entry; 2. Age: 30-70 years; 3. T2DM diagnosis according to the American Diabetes Association criteria since ≥6 months; 4. Stable metabolic control as indicated by levels of glycated hemoglobin (HbA1c) \<7.5% on two consecutive measurements before study enrollment; 5. Body mass index (BMI) level ≥30 Kg/m2 during the 3 months preceding randomization.
Exclusion criteria
1. Chronic treatment with corticosteroids and/or chronic treatment with non-steroidal inflammatory drugs, defined as ≥3 times/week with the rationale that these drugs independently impact on the whole inflammatory state; 2. Clear indication for dual antiplatelet therapy and/or anticoagulant therapy (full dose); 3. Active cancer or cancer in complete remission from less than one year, except for treated early-stage squamous or basal cell skin carcinomas; 4. For women with childbearing potential, pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | 12 months | Difference in body weight expressed in kg after 12 months between randomized arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 8-iso-Prostaglandin (PG) F2α | 12 months | Change on the oxidative status in vivo, as assessed by the measurement of the urinary excretion of the F2-isoprostane |
| 2,3-dinor-6-keto-PGF1α | 12 months | Change of the endothelial anti-thrombotic activity in vivo as assessed by the production of the vasodilator and platelet inhibitor prostanoid, prostacyclin (PGI2), major urinary enzymatic metabolite 2,3-dinor-6-keto-PGF1α |
| Interleukin (IL)-6 | 12 months | Change on inflammatory status assessed through the change of serum levels of interleukin (IL-6) |
| Glycemic variability | 12 months | Glycemic variability, as assessed by continuous glucose monitoring (CGM) |
| Waist circumference | 12 months | Change in waist circumference after 12 months between arms |
| Achieving the target weight loss | 12 months | Percentage of subjects who will reach the target percentage weight loss of 8% |
| Gut microbiota composition | 12 months | Gut microbiota composition, assessed by 16S RNA sequencing |
| C-reactive protein | 12 months | Change on inflammatory status assessed through the change of serum levels of C-reactive protein (CRP) |
Countries
Italy
Contacts
Primary ContactDario Pitocco
Outcome results
None listed