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

NCT ID: NCT05457088

Last Updated: 2022-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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intervention group

Dietary intervention with protein intake 1.5 gr/kg/day

Group Type EXPERIMENTAL

1.5 protein

Intervention Type OTHER

dietary plan having dietary protein of 1.5 gr/kg/day

control group

Dietary intervention with protein intake 0.8 gr/kg/day

Group Type EXPERIMENTAL

0.8 protein

Intervention Type OTHER

dietary plan having dietary protein of 0.8 gr/kg/day

Interventions

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1.5 protein

dietary plan having dietary protein of 1.5 gr/kg/day

Intervention Type OTHER

0.8 protein

dietary plan having dietary protein of 0.8 gr/kg/day

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harokopio University

OTHER

Sponsor Role collaborator

National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Vassilis Paschalis

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National and Kapodistrian University of Athens

Athens, Attica, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Vassilis Paschalis, Phd

Role: CONTACT

2107276033 ext. 0030

Facility Contacts

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Vassilis Paschalis, PhD

Role: primary

00302107276033

References

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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.

Reference Type RESULT
PMID: 35736019 (View on PubMed)

Other Identifiers

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1288/03-07-2021

Identifier Type: -

Identifier Source: org_study_id

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