Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Replacing Diet Beverages With Water on Weight Maintenance of Type 2 Diabetic Obese Women: 18 Months Follow up

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03726762
Recruitment Status : Completed
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Collaborators:
University of Nottingham
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Novindiet Clinic

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
the present study aimed to follow up our participants in order to consider the changes in weight and anthropometric measurements after the 12-month weight maintenance as well as the total of 18 months, consisting of the previously described 24 weeks active weight loss and a further 53 weeks weight maintenance. The secondary outcome was to compare the abdominal adiposity, carbohydrate, and lipid metabolism during these periods.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Overweight Obese Behavioral: DBs at the end of the main meal + weight control program Behavioral: Water at the end of the main meal+ weight control program Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Replacing Diet Beverages With Water on Type 2 Diabetic Obese Females Attending a Weight Loss Program - a Randomized, 24 Week Clinical Trial
Actual Study Start Date : April 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Diet Beverages
'Diet beverages' after the main meal
 Behavioral: DBs at the end of the main meal + weight control program
Subjects are asked to have 250 ml DBs at the end of their lunch as the main meal, while they are on a multidisciplinary diet plan.
Experimental: Water
'Water' after the main meal
 Behavioral: Water at the end of the main meal+ weight control program
Subjects are asked to have 250 ml water at the end of their lunch as the main meal, while they are on a multidisciplinary diet plan.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Weight loss [ Time Frame: 77 weeks ]

Secondary Outcome Measures :
  1. Fasting plasma glucose [ Time Frame: 77 weeks ]
  2. Insulin resistance (HOMA) [ Time Frame: 77 weeks ]
  3. Lipid profiles [ Time Frame: 77 weeks ]
  4. Waist circumference [ Time Frame: 77 weeks ]
  5. BMI [ Time Frame: 77 Weeks ]
  6. HA1C [ Time Frame: 77 Weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetic female patient with 6.5<H1AC<7.2.
  • Monotherapy with Metformin.
  • 18-45 years of age.
  • Body mass index (BMI) between 27-35 kg/ m².
  • Consume DBs regularly during their habitual diet.
  • Must be able to have moderate exercise.
  • Must be interested to have weight loss.

Exclusion Criteria:

  • Participating in a research project involving weight loss or physical activity in the previous six months.
  • Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
  • Taking medication that could affect metabolism or change body weight.
  • Report heart problems, chest pain, and cancer within the last five years.
  • Unwilling to change intake of beverages during the study period.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726762


Locations
Layout table for location information
Iran, Islamic Republic of
NovinDiet Clinic
Tehran, Iran, Islamic Republic of, 1913635136
Sponsors and Collaborators
Novindiet Clinic
University of Nottingham
Tehran University of Medical Sciences
Investigators
Layout table for investigator information
Study Chair: Hamid R Farshchi, MD, PhD NovinDiet Clinic, School of Life Sciences, The University of Nottingham
Principal Investigator: Ameneh Madjd, Dr NovinDiet Clinic, School of Life Sciences, The University of Nottingham
Principal Investigator: Ian A Macdonald, Prof. School of Life Sciences, The University of Nottingham
Principal Investigator: Moira A Taylor, PhD School of Life Sciences, The University of Nottingham
Principal Investigator: Reza Malekzadeh, Prof. Digestive Disease Research Institute, Tehran University of Medical Sciences
Principal Investigator: Alireza Delavari, MD Digestive Disease Research Institute, Tehran University of Medical Sciences
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Novindiet Clinic
ClinicalTrials.gov Identifier: NCT03726762    
Other Study ID Numbers: ND-307
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Novindiet Clinic:
diet beverages
water
diabetes
weight loss
insulin sensitivity
Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Body Weight