Clinical trial NCT03785379: A Trial Evaluating the Effects of a One-year Lifestyle Intervention in Obese Patients With Type 2 Diabetes
Official title: A Randomized Trial Evaluating the Effects of One-Year Caloric Restriction and 12-Week Exercise Training Intervention in Obese Adults With Type 2 Diabetes: Emphasis on Metabolic Control and Resting Metabolic Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Obesity
Lifestyle intervention
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 23
Sex: ALL
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After the baseline assessment, patients will be randomly assigned either to: 1) 1-year caloric restriction with an immediate start of 12-week supervised structured exercise training (SSET) (Early-SSET intervention), followed by no exercise at health centers for 3 months; or: 2) 1-year caloric restriction with no exercise at health centers for 3 months and then a 12-week SSET from month 4 to month 6 (Late-SSET intervention). During the last 6 months participants' activity will be unrestricted.
Primary purpose: TREATMENT

Brief summary: Diabetic patients with uncontrolled disease are often characterized by increased energy expenditure and could thus present a high resting metabolic rate (RMR). Lifestyle interventions aimed at improving glucose control in these patients may lead to reductions of futile pathways, resulting in lower rates of energy expenditure, and paradoxically to making it more difficult to lose weight. However, only few studies investigated how exercise could influence patients' RMR and results are still not unanimous. In this study, we aim to investigate the effects on metabolic health of a combined dietary intervention and 12-week exercise training in obese adults with type 2 diabetes.

Detailed description: Although a number of exercise training interventions have been proposed to type 2 diabetes patients, the current clinical practice demonstrates that most patients are still sedentary and with excess body weight. A negative balance between energy intake and energy expenditure is crucial to reduce excess body weight. However, diabetic patients with uncontrolled disease are often characterized by increased energy expenditure and could thus present a high resting metabolic rate (RMR). Lifestyle interventions aimed at improving glucose control in these patients may lead to reductions of futile pathways, resulting in lower rates of energy expenditure, and paradoxically to making it more difficult to lose weight. However, no robust evidence has been collected on this issue, and the few studies that investigated how exercise could influence patients' RMR have not shown unanimous results, especially concerning combined dietary and physical activity interventions.

This open-label randomized trial in obese adults with type 2 diabetes aims to investigate the effects of a 1-year caloric restriction and 12-week exercise training intervention on metabolic health, RMR and VO2max.

In particular, eligible type 2 diabetes patients of our clinic will be invited to participate in a short lifestyle intervention (LSI). LSI will consist of four weekly group-led lessons lasting 60-90 minutes in which specialized professionals will educate patients on specific dietary and physical activity recommendations for improving health and metabolic control.

After this month, patients will be randomly assigned either to: 1) 1-year caloric restriction with an immediate start of 12-week supervised structured exercise training (SSET) (Early-SSET intervention), followed by no exercise at health centers for 3 months; or: 2) 1-year caloric restriction with no exercise at health centers for 3 months and then a 12-week SSET from month 4 to month 6 (Late-SSET intervention). During the last 6 months participants' activity will be unrestricted.

Type 2 diabetic and obese adult volunteers will be recruited and screened through medical history, physical examination and biochemical analyses.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* age 30 to 64 years
* less than 60 min aerobic exercise/week
* absence of acute diseases
* no current treatment with insulin or sulfonylureas

Exclusion Criteria:

* Body mass index (BMI)\<28
* HbA1c\<6%
* Recent acute diseases, severe infections, trauma or surgery
* Uncontrolled hypertension or hyperglycemia
* Evidence of advanced cardiovascular, renal or hepatic diseases
* Contraindication to exercise
* Body weight change of more than 3% within the last 6 months
* Medication changes within the last 3 months

Primary outcomes:
measure: Change from baseline Glycated Hemoglobin (HbA1c) at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline Resting Metabolic Rate at 3 months
timeFrame: 3 months
measure: Change from baseline Resting Metabolic Rate at 6 months
timeFrame: 6 months
measure: Change from baseline Resting Metabolic Rate at 12 months
timeFrame: 12 months
measure: Change from baseline Body mass index at 3 months
timeFrame: 3 months
measure: Change from baseline Body mass index at 6 months
timeFrame: 6 months
measure: Change from baseline Body mass index at 12 months
timeFrame: 12 months
measure: Change from baseline Fat-free mass at 3 months
timeFrame: 3 months
measure: Change from baseline Fat-free mass at 6 months
timeFrame: 6 months
measure: Change from baseline Fat-free mass at 12 months
timeFrame: 12 months
measure: Change from baseline android to gynoid percent fat ratio at 3 months
timeFrame: 3 months
measure: Change from baseline android to gynoid percent fat ratio at 6 months
timeFrame: 6 months
measure: Change from baseline android to gynoid percent fat ratio at 12 months
timeFrame: 12 months
measure: Change from baseline fasting plasma glucose at 3 months
timeFrame: 3 months
measure: Change from baseline fasting plasma glucose at 6 months
timeFrame: 6 months
measure: Change from baseline fasting plasma glucose at 12 months
timeFrame: 12 months
measure: Change from baseline HDL cholesterol at 3 months
timeFrame: 3 months
measure: Change from baseline HDL cholesterol at 6 months
timeFrame: 6 months
measure: Change from baseline HDL cholesterol at 12 months
timeFrame: 12 months
measure: Change from baseline total cholesterol at 3 months
timeFrame: 3 months
measure: Change from baseline total cholesterol at 6 months
timeFrame: 6 months
measure: Change from baseline total cholesterol at 12 months
timeFrame: 12 months
measure: Change from baseline triglycerides levels at 3 months
timeFrame: 3 months
measure: Change from baseline triglycerides levels at 6 months
timeFrame: 6 months
measure: Change from baseline triglycerides levels at 12 months
timeFrame: 12 months
measure: Change from baseline serum creatinine at 3 months
timeFrame: 3 months
measure: Change from baseline serum creatinine at 6 months
timeFrame: 6 months
measure: Change from baseline serum creatinine at 12 months
timeFrame: 12 months
measure: Change from baseline urinary albumin-to-creatinine ratio at 3 months
timeFrame: 3 months
measure: Change from baseline urinary albumin-to-creatinine ratio at 6 months
timeFrame: 6 months
measure: Change from baseline urinary albumin-to-creatinine ratio at 12 months
timeFrame: 12 months
measure: Change from baseline maximal aerobic power at 3 months
timeFrame: 3 months
measure: Change from baseline maximal aerobic power at 6 months
timeFrame: 6 months
measure: Change from baseline maximal aerobic power at 12 months
timeFrame: 12 months
measure: Change from baseline Glycated Hemoglobin (HbA1c) at 3 months
timeFrame: 3 months
measure: Change from baseline Glycated Hemoglobin (HbA1c) at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Padova
name: Francesco Zurlo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Mourier A, Gautier JF, De Kerviler E, Bigard AX, Villette JM, Garnier JP, Duvallet A, Guezennec CY, Cathelineau G. Mobilization of visceral adipose tissue related to the improvement in insulin sensitivity in response to physical training in NIDDM. Effects of branched-chain amino acid supplements. Diabetes Care. 1997 Mar;20(3):385-91. doi: 10.2337/diacare.20.3.385.
citation: Karstoft K, Brinklov CF, Thorsen IK, Nielsen JS, Ried-Larsen M. Resting Metabolic Rate Does Not Change in Response to Different Types of Training in Subjects with Type 2 Diabetes. Front Endocrinol (Lausanne). 2017 Jun 13;8:132. doi: 10.3389/fendo.2017.00132. eCollection 2017.
citation: Zurlo F, Trevisan C, Vitturi N, Ravussin E, Salvo C, Carraro S, Siffi M, Iob I, Saller A, Previato L, Sergi G, de Kreutzenberg S, Maran A, Avogaro A. One-year caloric restriction and 12-week exercise training intervention in obese adults with type 2 diabetes: emphasis on metabolic control and resting metabolic rate. J Endocrinol Invest. 2019 Dec;42(12):1497-1507. doi: 10.1007/s40618-019-01090-x. Epub 2019 Jul 29.