Effects of Caloric Restriction in Obesity and Type 2 Diabetes

NCT01930136 | Completed

• 1 other identifier: CRESO 2
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

The study investigates whether a long-term 25% caloric restriction can prevent onset and/or progression of renal function deterioration, retinal involvement and cardiovascular complications in overweight/obese type 2 diabetic patients, trough the amelioration of concomitant metabolic abnormalities such as visceral obesity, insulin resistance, dyslipidemia, hypertension and inflammation. The main aim of the study is therefore to evaluate the role of calorie restriction (CR) on subjects at risk of nephropathy. Secondary aims are to better understand the relationship between CR and the following aspects: renal disease and its associated metabolic abnormalities, retinopathy and cardiovascular complications, quality of life and treatment cost.

Conditions

Type 2 Diabetes; Obesity

Keywords

Calorie restriction; Type 2 diabetes; Obesity; Diabetic nephropathy prevention

Outcome Measures

Primary Outcomes (1)

• The percent change in glomerular filtration rate (GFR) at month 6 versus baseline and the rate of GFR decline from month 6 to study end

  At baseline, 6, 12 and 24 month

Study Arms (2)

Calorie restriction (25%)

EXPERIMENTAL

CR will correspond to a reduction of 25% from the total daily calorie expenditure calculated as Total Daily Energy Expenditure (TDEE) (kcal/d) using the formula from the validated Seven-Day Physical Activity Recall (PAR) Questionnaire (RMR x activity levels).

Behavioral: Calorie restriction (25%)

Ad libitum health diet

ACTIVE COMPARATOR

Behavioral: Ad libitum health diet

Interventions

Calorie restriction (25%) BEHAVIORAL

Calorie restriction (25%)

Ad libitum health diet BEHAVIORAL

Ad libitum health diet

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>40 years;
• Type 2 diabetes (ADA criteria);
• UAE \<300 mg/24h;
• Body mass index (BMI)\>27kg/m2;
• Serum creatinine \< 1.2 mg/dL;
• No major changes in calorie, protein and sodium intake in the last 6 mos;
• No major changes in concomitant treatments with blood pressure, glucose or lipid lowering agents since 6 and 3 months respectively;
• Patients legally able to give written informed consent to the trial (signed and dated by the patient);
• Written informed consent.

You may not qualify if:

• Concomitant non-diabetic renal disease or ischemic kidney disease;
• Primary or immune-mediated renal disease;
• Urinary tract obstruction or infection;
• Treatment with steroids and/or non-steroid anti-inflammatory agents;
• Treatment with thiazide or loop diuretics that, on the basis of the Investigator's judgment, might sustain hypovolemia and/or sodium depletion (with secondary kidney hypoperfusion/hypofiltration);
• Hearth failure and/or hemodynamically significant left ventricular systolic dysfunction, cirrhosis, uncontrolled hyperglycemia resulting in glycosuria, hyper/hyponatremia of any cause;
• Previous surgical procedures for weight loss;
• Previous episodes of depression, or suicide attempts;
• Chronic abuse of alcohol and drugs;
• Pregnancy, ineffective contraception or peri-menopausal age;
• Cancer or any chronic disease that might affect the completion of the study;
• Chronic obstructive pulmonary disease (COPD) in treatment with positive airway pressure;
• Unwillingness or inability to adhere to CR intervention over the entire 24-months intervention period;
• Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial;
• Evidence of an uncooperative attitude;

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead
• Istituto Superiore di Sanità: collaborator

Study Sites (1)

Clinical Research Center for Rare Diseases

Ranica, Bergamo, 24020, Italy

Location

Related Publications (1)

• Ruggenenti P, Cortinovis M, Trillini M, Parvanova A, Abbate M, Satriano C, Salvetti F, Bossi AC, Trevisan R, Perna A, Peracchi T, Rubis N, Diadei O, Martinetti D, Gaspari F, Fontana L, Remuzzi G; CRESO 2 Study; Organization. Long-term kidney and systemic effects of calorie restriction in overweight or obese type 2 diabetic patients (C.Re.S.O. 2 randomized controlled trial). Diabetes Res Clin Pract. 2022 Mar;185:109804. doi: 10.1016/j.diabres.2022.109804. Epub 2022 Feb 24.

  PMID: 35219762 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: August 28, 2013
• Study Start: May 1, 2013
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

IT (1)