Overweight and Obesity in Relation to Type ll Diabetes Melitus

September 16, 2022 updated by: Given Chipili, Mukuba University

Overweight and Obesity in Relation to Type II Melitus,Diabetes A Randomised Controlled Trial

The aim of the study is to evaluate the efficacy of local Zambian food in improving metabolic profiles of overweight/obese type ll diabetic patients in Kitwe district

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Zambia
    • Copperbelt
      • Kitwe, Copperbelt, Zambia, 50100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetic patients attending Kitwe Teaching Hospital
  • 18 years and above
  • Body Mass Index of 25 and above
  • Willing to follow the diet plan and eat food provided
  • Not enrolled in other clinical studies

Exclusion Criteria:

  • Eating disorder or any psychosocial or scheduling factors that could impede study outcomes
  • Have renal or liver problem
  • Pregnant women
  • Breast feeding women
  • HIV positive individuals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
Participants in the intervention group will receive local zambian foods and standard health care for eight (8) weeks.
Dietary supplement: Local Zambian Foods
Each week, participants in the intervention group will collect a pack of foodstuffs to last a week from the research site. The packs will be adjusted according to the weight of the participant and daily recommended allowances. Packaging of foodstuffs will be done in the food service lab at the Mukuba University. Instructions on how to prepare and use the food will be given to the participants. All food Items will be labelled diabetic food to avoid intra-household sharing.
No Intervention: Control arm
The control group will have their usual (standard) diet in their home and receive standard health care for eight (8) weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood glucose levels
Time Frame: At baseline and 8 weeks
Fingertip blood sugar test using: blood glucose meter, test strips, lancet device, dry swabs, methylated spirit and a sharps box.
At baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body weight
Time Frame: At baseline and 8 weeks
Weight will be measured using the Seca adult scale
At baseline and 8 weeks
Change of Body Mass Index (BMI)
Time Frame: At baseline and 8 weeks
Hand held BMI machine will be used to determine the BMI of each participant.
At baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mukuba University

Collaborators

University of Zambia
National Science and Technology Council
Afe Babalola University, Nigeria
Buea University, Cameroon
Sokoine University of Agriculture
Kitwe Teaching Hospital, Zambia

Investigators

  • Principal Investigator: Given Chipili, Mukuba University, Kitwe, Zambia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 30, 2023

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

October 15, 2023

Study Registration Dates

First Submitted

July 7, 2019

First Submitted That Met QC Criteria

July 9, 2019

First Posted (Actual)

July 11, 2019

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 16, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU0619

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data collected in this study will be published online

IPD Sharing Time Frame

6 months after the study ends.

IPD Sharing Access Criteria

Mukuba University Website

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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