Clinical trial NCT06223490: Effect of Cryolipolysis on Insulin Resistance
Official title: Effect of Cryolipolysis on Insulin Resistance in Type 2 Diabetic Females With Abdominal Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus in Obese
Cryotherapy Effect
Keywords: TII DM
Obese Females
Cryolipolysis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Diabetes mellitus (DM) is a complex chronic illness associated with a state of high blood glucose level, or hyperglycemia, occurring from deficiencies in insulin secretion, action, or both.

Diabetes mellitus is the name given to a wide spectrum group of disorders characterized by raised plasma glucose.Type 1 diabetes is characterized by an absolute insulin deficiency due to autoimmune destruction of insulin producing beta cells in the pancreas.

most adults with diabetes have type 2, characterized by a relative insulin secretory defect, and target tissue resistance to the effects of insulin.

Detailed description: Diabetes is one of the most important health problems and chronic metabolic diseases requiring critical care.The number of people with diabetes has risen from 108 million in 1980 to 422 million in 2014.

Type 2 diabetes mellitus is a common and increasingly prevalent disease and is thus a major public health concern worldwide. The International Diabetes Federation estimates that there are approximately 387 million people diagnosed with diabetes across the globe.

The clinical diagnosis of diabetes is reliant on either one of the four plasma glucose (PG) criteria: elevated (i) fasting plasma glucose (FPG) (\>126 mg/dL), (ii) 2 h PG during a 75-g oral glucose tolerance test (OGTT) (\>200 mg/dL), (iii) random PG (\>200 mg/dL) with classic signs and symptoms of hyperglycemia, or (iv) hemoglobin A1C level \>6.5%.

The principal tissues affected by insulin resistance are liver, muscle and fat. In the liver this impaired insulin related inhibition of hepatic gluconeogenesis results in increased hepatic glucose output, exacerbating hyperglycemia.

In muscle, reduced transport of carbohydrates into muscle combined with lipid deposition in muscle cells leads toimpaired exercise ability and lowered threshold for tiredness with exercise. In fat tissue, there is impaired insulin-mediated inhibition of hormone dependent lipase, with breakdown of lipids to free fatty acids and glycerol, contributing to the dyslipidemia. With the rise in diabetes prevalence, researchers have increasingly investigated treatments intended to improve health and quality of life. People are much more likely to achieve metabolic control when they adhere to recommended diets, medications and exercise behaviors.

Cryolipolysis (CoolSculpting, Zeltiq, Pleasanton, CA) is a novel method of selective removal of fat with cooling. This technique is basedon the concept that fat cells are more sensitive to cold than the surrounding tissue. Prior studies and observations have demonstrated that cold exposure can induce selective damage to the subcutaneous fat via induction of panniculitis, resulting in reduction in the superficial fat layer of the skin

Eligibility criteria: Inclusion Criteria:

* Patients with incidence of diabetes 5 years ago.
* Patient fasting glucose level is more than 140 mg/dL.
* Age will be ranged from 35 to 45 years
* Body mass index between 25 and 30.
* All patients are medically controlled
* All patients have the same medical care.
* All patients will receive a good explanation of treatment procedures.

Exclusion Criteria:

* Patients dependent on insulin.
* Renal failure.
* Myocardial infractions.
* Cardiovascular problems.
* Neurological disorders.
* Patients with orthopedic problems (e.g mal or incomplete union of fracture, ankle sprains.
* Abdominal hernia
* Skin disease
* Unstable cases

Primary outcomes:
measure: Skin fold thickness and estimation of total body fat
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
Study officials:
affiliation: Cairo University
name: Akram Abd El Aziz, Assist.Prof
role: STUDY_CHAIR
References: