UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004717
Receipt number R000005614
Scientific Title Effects of a low-carbohydrate diet on carotid artery intima-media thickness,urinary albumin excretion and eGFR in patients with type 2 diabetes: a 2-year intervention study
Date of disclosure of the study information 2011/01/01
Last modified on 2015/02/25 20:24:27

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Basic information

Public title

Effects of a low-carbohydrate diet on carotid artery intima-media thickness,urinary albumin excretion and eGFR in patients with type 2 diabetes: a 2-year intervention study

Acronym

Effects of a low-carbohydrate diet on atherosclerosis in type 2 diabetes

Scientific Title

Effects of a low-carbohydrate diet on carotid artery intima-media thickness,urinary albumin excretion and eGFR in patients with type 2 diabetes: a 2-year intervention study

Scientific Title:Acronym

Effects of a low-carbohydrate diet on atherosclerosis in type 2 diabetes

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Cardiology Endocrinology and Metabolism Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To comfirm effects of a low-carbohydrate diet for two years on carotid artery intima-media thickness,urinary albumin excretion and eGFR among patients with type 2 diabetes.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Carotid artery intima-media thickness measured by echography, urinary albumin excretion, eGFR, BMI, fasting plasma glucose, serum insulin, HbA1c and serum lipid profiles

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

A carbohydratelow-carbohydrate diet (diatary %energy from carbohydrates ranging from 30% to 40%)

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

30 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with type 2 diabetes

Key exclusion criteria

Patients with serum creatinine levels greater than 1.5mg/dl, severe diabetes complications, ketoacidosis, soft drink ketosis, cancer, severe heart failure or liver cirrhosis

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hajime Haimoto

Organization

Haimoto Clinic

Division name

Department of internal medicine

Zip code


Address

1-80 Yayoi, Kasugai, Aichi

TEL

0568-85-0567

Email

haimoto@gol.com


Public contact

Name of contact person

1st name
Middle name
Last name Hajime Haimoto

Organization

Haimoto Clinic

Division name

Department of internal medicine

Zip code


Address

1-80 Yayoi, Kasugai, Aichi

TEL

0568-85-0567

Homepage URL


Email

haimoto@gol.com


Sponsor or person

Institute

Haimoto Clinic

Institute

Department

Personal name



Funding Source

Organization

Haimoto Clinic

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Preventive Medicine, Nagoya University Graduate School of Medicine

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2011 Year 01 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.nutritionandmetabolism.com/content/11/1/33

Number of participants that the trial has enrolled


Results

At baseline, the mean HbA1c level and carbohydrate intake were 6.9 +/- 0.4% and 252 +/- 59 g/day for Group 1(n = 55), 8.1 +/- 0.4% and 282 +/- 85 g/day for Group 2 (n=41) and 10.6 +/- 1.4% and 309 +/- 88 g/day for Group 3 (n = 26). Following three-graded carbohydrate restriction for 6 months significantly decreased mean carbohydrate intake (g/day) and HbA1c levels for all patients, from 274 +/- 78 to168 +/- 52 g and from 8.1 +/- 1.6 to 7.1 +/- 0.9% (n = 122, P < 0.001 for both) and anti-diabetic drugs could be tapered. Delta-HbA1c and delta-carbohydrate were -0.4 +/- 0.4% and -74 +/- 69 g/day for Group 1, -0.6 +/- 0.9% and -117 +/- 78 g/day for Group 2 and -3.1 +/- 1.4% and -156 +/- 74 g/day for Group 3. The greater the reduction in carbohydrate intake (g/day), the greater the decrease in HbA1c levels (P < 0.001).

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2010 Year 11 Month 15 Day

Date of IRB


Anticipated trial start date

2010 Year 12 Month 01 Day

Last follow-up date

2013 Year 06 Month 30 Day

Date of closure to data entry

2013 Year 09 Month 30 Day

Date trial data considered complete

2013 Year 10 Month 31 Day

Date analysis concluded

2013 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2010 Year 12 Month 13 Day

Last modified on

2015 Year 02 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005614


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name