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High Protein Effect on Body Composition and Sarcopenia Markers in Older Patients With Type 2 Diabetes Mellitus

Primary Purpose

Type2 Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
1.5 protein
0.8 protein
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type2 Diabetes Mellitus focused on measuring older adults, dietary protein, nutrition intervention, sarcopenia, performance, oxidative stress, inflammation, biochemical profile

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • must have been diagnosed with type 2 diabetes mellitus during the last 5 years
  • must have BMI 18.5-24.9

Exclusion Criteria:

  • receive dietary supplements
  • extreme dietary habits
  • chronic inflammation disease
  • cancer
  • autoimmune disease

Sites / Locations

  • National and Kapodistrian University of AthensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

intervention group

control group

Arm Description

Dietary intervention with protein intake 1.5 gr/kg/day

Dietary intervention with protein intake 0.8 gr/kg/day

Outcomes

Primary Outcome Measures

skeletal muscle mass index
Change from baseline in skeletal muscle mass index and will be assessed by dual energy x-ray absorptiometry ((leg lean mass+arm lean mass)/height^2)
calf circumference
Change from baseline in calf circumference and will be assessed by measuring tape
handgrip strength
Change from baseline in handgrip strength and will be assessed by handgrip dynamometer
Sit to stand test
Change from baseline in "Sit to stand" test which measures muscle functionality and will be assessed by chronometer
Timed up and go test
Change from baseline in "Timed up and go" test which measures muscle functionality and will be assessed by chronometer
10 meters walking test
Change from baseline in 10 meters walking test which measures muscle functionality and will be assessed by chronometer
blood glucose
Change from baseline in blood glucose and will be assessed by commercially available kit
Serum insulin
Change from baseline in serum insulin and will be assessed by commercially available kit
Glycosylated hemoglobin (HbA1)
Change from baseline in HbA1 and will be assessed by commercially available kit
C reactive protein
Change from baseline in C reactive protein and will be assessed by commercially available kit
Dietary intake of macro- and micro-nutrients
Change from baseline in macro- and micro- nutrients and will be assessed with -3 day recall

Secondary Outcome Measures

cholesterol level
Change from baseline in cholesterol level and will be assessed by commercially available kit
triglycerides level
Change from baseline in triglycerides level and will be assessed by commercially available kit
low-density lipoprotein (LDL)
Change from baseline in LDL and will be assessed by commercially available kit
high-density lipoprotein (HDL)
Change from baseline in HDL and will be assessed by commercially available kit
Enzymatic activity of glutathione peroxidase in plasma
Change from baseline in enzymatic activity of glutathione peroxidase in plasma and will be assessed by commercially available kit
Enzymatic activity of glutathione peroxidase in red blood cell lysate
Change from baseline in enzymatic activity of glutathione peroxidase in red blood cell lysate and will be assessed by commercially available kit
Enzymatic activity of superoxide dismutase in plasma
Change from baseline in superoxide dismutase in plasma and will be assessed by commercially available kit
Enzymatic activity of superoxide dismutase in red blood cell lysate
Change from baseline in superoxide dismutase in red blood cell lysate and will be assessed by commercially available kit
Protein carbonyls in plasma
Change from baseline in protein carbonyls in plasma and will be assessed by commercially available kit

Full Information

First Posted
July 8, 2022
Last Updated
July 8, 2022
Sponsor
National and Kapodistrian University of Athens
Collaborators
Harokopio University
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1. Study Identification

Unique Protocol Identification Number
NCT05457088
Brief Title
High Protein Effect on Body Composition and Sarcopenia Markers in Older Patients With Type 2 Diabetes Mellitus
Official Title
The Effect of High Protein on Body Composition and Markers of Sarcopenia in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens
Collaborators
Harokopio University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will investigate the impact of dietary protein intake on progressive muscle loss and functionality (sarcopenia) in older adults with type 2 diabetes mellitus. Sarcopenia is known to have a bidirectional interaction with type 2 diabetes mellitus. Therefore in order to address this bidirectional complication we suggest that an increased intake of dietary protein at 1.5 gr/kg/day (current official recommendation is 0.8 gr/kg/day) could help to treat the sarcopenia, which in turn will help to ameliorate the type 2 diabetes mellitus progression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes Mellitus
Keywords
older adults, dietary protein, nutrition intervention, sarcopenia, performance, oxidative stress, inflammation, biochemical profile

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1st group will receive a dietary plan having dietary protein of 1.5gr/kg/day.2nd group will receive a dietary plan having dietary protein of 0.8gr/kg/day.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
Dietary intervention with protein intake 1.5 gr/kg/day
Arm Title
control group
Arm Type
Experimental
Arm Description
Dietary intervention with protein intake 0.8 gr/kg/day
Intervention Type
Other
Intervention Name(s)
1.5 protein
Intervention Description
dietary plan having dietary protein of 1.5 gr/kg/day
Intervention Type
Other
Intervention Name(s)
0.8 protein
Intervention Description
dietary plan having dietary protein of 0.8 gr/kg/day
Primary Outcome Measure Information:
Title
skeletal muscle mass index
Description
Change from baseline in skeletal muscle mass index and will be assessed by dual energy x-ray absorptiometry ((leg lean mass+arm lean mass)/height^2)
Time Frame
Week 0, week 12
Title
calf circumference
Description
Change from baseline in calf circumference and will be assessed by measuring tape
Time Frame
Week 0, week 6, week 12
Title
handgrip strength
Description
Change from baseline in handgrip strength and will be assessed by handgrip dynamometer
Time Frame
Week 0, week 6, week 12
Title
Sit to stand test
Description
Change from baseline in "Sit to stand" test which measures muscle functionality and will be assessed by chronometer
Time Frame
Week 0, week 6, week 12
Title
Timed up and go test
Description
Change from baseline in "Timed up and go" test which measures muscle functionality and will be assessed by chronometer
Time Frame
Week 0, week 6, week 12
Title
10 meters walking test
Description
Change from baseline in 10 meters walking test which measures muscle functionality and will be assessed by chronometer
Time Frame
Week 0, week 6, week 12
Title
blood glucose
Description
Change from baseline in blood glucose and will be assessed by commercially available kit
Time Frame
Week 0, week 6, week 12
Title
Serum insulin
Description
Change from baseline in serum insulin and will be assessed by commercially available kit
Time Frame
Week 0, week 6, week 12
Title
Glycosylated hemoglobin (HbA1)
Description
Change from baseline in HbA1 and will be assessed by commercially available kit
Time Frame
Week 0, week 6, week 12
Title
C reactive protein
Description
Change from baseline in C reactive protein and will be assessed by commercially available kit
Time Frame
Week 0, week 6, week 12
Title
Dietary intake of macro- and micro-nutrients
Description
Change from baseline in macro- and micro- nutrients and will be assessed with -3 day recall
Time Frame
Week 0, week 3 , week 6, week 9, week 12
Secondary Outcome Measure Information:
Title
cholesterol level
Description
Change from baseline in cholesterol level and will be assessed by commercially available kit
Time Frame
Week 0, week 6, week 12
Title
triglycerides level
Description
Change from baseline in triglycerides level and will be assessed by commercially available kit
Time Frame
Week 0, week 6, week 12
Title
low-density lipoprotein (LDL)
Description
Change from baseline in LDL and will be assessed by commercially available kit
Time Frame
Week 0, week 6, week 12
Title
high-density lipoprotein (HDL)
Description
Change from baseline in HDL and will be assessed by commercially available kit
Time Frame
Week 0, week 6, week 12
Title
Enzymatic activity of glutathione peroxidase in plasma
Description
Change from baseline in enzymatic activity of glutathione peroxidase in plasma and will be assessed by commercially available kit
Time Frame
Week 0, week 6, week 12
Title
Enzymatic activity of glutathione peroxidase in red blood cell lysate
Description
Change from baseline in enzymatic activity of glutathione peroxidase in red blood cell lysate and will be assessed by commercially available kit
Time Frame
Week 0, week 6, week 12
Title
Enzymatic activity of superoxide dismutase in plasma
Description
Change from baseline in superoxide dismutase in plasma and will be assessed by commercially available kit
Time Frame
Week 0, week 6, week 12
Title
Enzymatic activity of superoxide dismutase in red blood cell lysate
Description
Change from baseline in superoxide dismutase in red blood cell lysate and will be assessed by commercially available kit
Time Frame
Week 0, week 6, week 12
Title
Protein carbonyls in plasma
Description
Change from baseline in protein carbonyls in plasma and will be assessed by commercially available kit
Time Frame
Week 0, week 6, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: must have been diagnosed with type 2 diabetes mellitus during the last 5 years must have BMI 18.5-24.9 Exclusion Criteria: receive dietary supplements extreme dietary habits chronic inflammation disease cancer autoimmune disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vassilis Paschalis, Phd
Phone
2107276033
Ext
0030
Email
vpaschalis@phed.uoa.gr
Facility Information:
Facility Name
National and Kapodistrian University of Athens
City
Athens
State/Province
Attiki
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vassilis Paschalis, PhD
Phone
00302107276033
Email
vpaschalis@phed.uoa.gr
First Name & Middle Initial & Last Name & Degree
Dionysia Argyropoulou, Msc
First Name & Middle Initial & Last Name & Degree
Vassilis Paschalis, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
35736019
Citation
Argyropoulou D, Geladas ND, Nomikos T, Paschalis V. Exercise and Nutrition Strategies for Combating Sarcopenia and Type 2 Diabetes Mellitus in Older Adults. J Funct Morphol Kinesiol. 2022 Jun 8;7(2):48. doi: 10.3390/jfmk7020048.
Results Reference
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High Protein Effect on Body Composition and Sarcopenia Markers in Older Patients With Type 2 Diabetes Mellitus

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