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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02568020
Other study ID # Keto-019-IP3
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received September 30, 2015
Last updated October 31, 2016
Start date November 2016
Est. completion date May 2019

Study information

Verified date October 2016
Source Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To investigate the effects of different dietary regimens on muscle wasting, insulin/IGF-1 resistance. Further, to explore whether LPD+KA decrease the activation of autophagy associate with insulin/IGF-1 pathway.


Description:

1. Dietary assessment: The composition of the diet will be evaluated through questionnaire, and analyzed a computer-based nutritional evaluation with Dieta software.

2. Biochemical data: blood samples will be collected at baseline and every 3 months of routine examination, such as blood routine, biochemistry, HbA1c, Serum IGF-1, CRP, will be measured. Homeostatic model assessment score (HOMA-IR) was recorded.

3. Skeletal muscle assessment: the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. Body weight, height, Body mass index, skeletal muscle mass will be measured by Body composition analyzer. Quadriceps strength will be assessed with a seated leg press exercise instrument (Keiser Sport, Fresno, CA, USA) using the five repetition maximum technique. Knee and hip extension power (rate of generating force) will be assessed with a validated leg power instrument (University ofNottingham Medical College, Nottingham, UK). Fatigability will be assessed with the same bilateral leg press exercise used in strength testing.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date May 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- patients agree to participate in this study; age=18 years and<70years; renal function measured with creatinine clearance<60 and >15 ml/min (three monthly consecutive measurements);at least 6 months of follow up at our clinic before recruitment and haven't received any diet intervention.

Exclusion Criteria:

- pregnant patients; diabetes; heart or liver failure; a recent myocardial infarction (in the last 12 months); long term immobilization; chronic respiratory failure; cancer; any pharmacological treatment that could modify muscle structure or function such as glucocorticoids or insulin;Contraindications of Ketosteril, such as hypersensitivity to the active substances or to any of the excipients, hypercalcaemia, disturbed amino acid metabolism to the study protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
keto-amino acids
Ketosteril®( Fresenius Kabi) will be given at a dosage of one tablet/5kg ideal body weight/day, divided into three doses taken during meals.The patients will be followed-up for one year. The patients will come to the hospital every 4 weeks.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
YUAN Wei-jie

Outcome

Type Measure Description Time frame Safety issue
Primary Body weight assessment the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. Body weight will be measured to calculate Body mass index. 1 year Yes
Primary skeletal muscle mass the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. muscle circumference including mid-arm, mid-thigh, and mid-calf circumferences will be assessed. 1 year Yes
Primary Quadriceps strength assessment the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. Quadriceps strength will be assessed with a seated leg press exercise instrument (Keiser Sport, Fresno, CA, USA) using the five repetition maximum technique. 1 year Yes
Primary Knee and hip extension power assessment the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. Knee and hip extension power (rate of generating force) will be assessed with a validated leg power instrument (University ofNottingham Medical College, Nottingham, UK). 1 year Yes
Primary Fatigability assessment the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. Fatigability will be assessed with the same leg power instrument (University ofNottingham Medical College, Nottingham, UK) as used in strength testing. 1 year Yes
Primary Height assessment the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. Height will be measured to calculate Body mass index 1 year Yes
Secondary Dietary assessment The composition of the diet will be evaluated through questionnaire 1 year Yes
Secondary computer-based nutritional assessment analyzed a computer-based nutritional evaluation with Dieta software. 1 year Yes
Secondary Biochemical data blood samples will be collected at baseline and every 3 months of routine examination, such as blood routine, biochemistry, HbA1c, Serum IGF-1, CRP, will be measured. 1 year Yes
Secondary calculate HOMA-IR Homeostatic model assessment score (HOMA-IR) was recorded. 1 year Yes
Secondary Safety parameters Blood routine:including WBC, RBC, Hb, PLT, HCT; Blood biochemistry:including Ca, P, iPTH, albumin, prealbumin, transferrin, creatinine, Bun,CRP Blood fat: cholesterol, triglyceride(VLDL?LDL?HDL) 1 year Yes
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