Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/11/2016
Date assigned
22/11/2016
Last edited
10/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Type 2 diabetes mellitus (T2DM) is a growing problem worldwide. People with T2DM have difficulty controlling their blood sugar (glucose) as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). Prediabetes is a condition where a person’s blood sugar levels are higher than normal, but nor high enough to be classified as T2DM. If left untreated, then prediabetes can turn into T2DM. In people with T2DM and diabetes, when sugar is consumed it causes blood sugar levels to rise as there is not enough insulin (or the insulin is ineffective) to store the sugar for when it’s needed later. KarboLyn® is a designer sugar originally developed for athletes interested in carbohydrate loading (a technique used to maximize storage of energy for exercise). It has been shown to be quickly stored in the body without the ending ‘crash’ that often accompanies these energy bursts. The aim of this study is to look at the way KarboLyn® is broken down and stored in healthy volunteers and those with prediabetes and T2DM compared to glucose.

Who can participate?
In part one, healthy volunteers and those with prediabetes aged 21 or over can take part.
In part two, diabetics aged 21 or over can take part.

What does the study involve?
In part one, participants are asked to fast for eight hours before the study visit and are randomly allocated to one of two groups. Those in the first group consume 50g KarboLyn® and those in the second group consume 50g glucose (sugar). All participants are then asked to walk on a treadmill for two hours. At the start of the study and then 15, 30, 45, 60, 75, 90, 105, and 120 minutes after consuming the sugar, participants stop and have a blood sample taken which is used to measure blood sugar levels.
In part two, participants are asked to fast for eight hours before the study visit and not to take their diabetes medication. At the study visit, all participants consume 10g KarboLyn® and are then asked to walk on a treadmill for two hours. At the start of the study and then 15, 30, 45, 60, 75, 90, 105, and 120 minutes after consuming the sugar, participants stop and have a blood sample taken which is used to measure blood sugar levels. One week later, participants return for a second study visit which is exactly the same except they consume 10g glucose instead.

What are the possible benefits and risks of participating?
There are no direct benefits involved with participating. There is a small chance of pain or discomfort when blood samples are taken. In part two, diabetic patients may experience a spike in blood sugar which may make them feel unwell.

Where is the study run from?
Montana Medical Research Incorporated (USA)

When is the study starting and how long is it expected to run for?
November 2013 to May 2016

Who is funding the study?
All American Pharmaceutical (USA)

Who is the main contact?
1. Ms Wendy Jones (scientific)
WLJ_1998@yahoo.com
2. Dr Jeff Golini (public)
jeffg@allamericanpharmaceutical.com

Trial website

Contact information

Type

Scientific

Primary contact

Ms Wendy Jones

ORCID ID

Contact details

Royal Knight Incorporated
1204 Harbor Drive SE
Ste - 100
Rochester
55904
United States of America
+1 507 289 8192
WLJ_1998@yahoo.com

Type

Public

Additional contact

Dr Jeff Golini

ORCID ID

http://orcid.org/0000-0002-4301-3800

Contact details

All American Pharmaceutical
2376 Main Street
Billings
59105
United States of America
+1 406 245 5793
jeffg@allamericanpharmaceutical.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

001

Study information

Scientific title

KarboLyn®, leads to glucose control in a pre-diabetic cohort

Acronym

Study hypothesis

The aim of this study is to observe the effect of KarboLyn® Vs glucose has on blood sugar response in normal, pre-diabetic, and Type 2 non-insulin dependent diabetic volunteers.

Ethics approval

Part 1: Quorum Review IRB Board, 07/01/2014, ref: 29443/1
Part 2: Integ-review Board, 13/05/2015, ref: KL003

Study design

Part 1: Randomised controlled trial
Part 2: Non-randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Diabetes

Intervention

Part 1:
After an 8-hour fast (minumum), normal and pre-diabetic volunteers are randomized to one of two groups.

Group 1: Participants receive 50g KarboLyn®
Group 2: Participants receive 50g glucose

Following consumption of the study sugar, participants are asked to walk on a treadmill (~1mph) for a period of 2 hours. At baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, and 120 minutes, participants stop and have blood samples drawn in order to measure blood glucose levels.

Part 2:
All diabetic volunteers are withdrawn from their oral diabetic medication for one cycle and fast for a minimum of 8 hours prior to commencement of the study. All participants receive KarboLyn® (10 grams) and are then asked to walk on a treadmill (~1mph) for a period of 2 hours. At baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, and 120 minutes, participants stop and have blood samples drawn in order to measure blood glucose levels.
After one week ‘off’, the same volunteers are treated in the above manner prior to receiving 10 grams of glucose. Blood draw conditions and timing are the same.

Intervention type

Phase

Drug names

Primary outcome measures

Blood sugar is measured by blood draws and standard glucose testing at ‘0’ (before consumption), and at 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, and 120 minutes for all volunteers.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/11/2013

Overall trial end date

13/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Part 1:
Healthy volunteers:
1. Aged 21 years and over
2. Healthy (not a pre-diabetic or diabetic)
3. Normal blood sugar level (fasting glucose is less than or equal to 100 mg/dl)

Pre-diabetics:
1. Aged 21 years and over
2. Pre-diabetic not currently taking any diabetic related medication to control blood sugar level
3. Fasting blood sugar is greater than 100 mg/dl and less than 130 mg/dl

Part 2:
1. Aged 21 years and over
2. Diabetic (fasting blood sugar is between 125 mg/dl and 200 mg/dl)

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Normal controls: 24 / pre-diabetics: 12 / Type 2 diabetics: 6

Participant exclusion criteria

Parts 1 and 2:
1. Pregnancy
2. Heath condition making participant unable to walk on a treadmill for 2 hours

Recruitment start date

01/07/2014

Recruitment end date

21/12/2015

Locations

Countries of recruitment

United States of America

Trial participating centre

Montana Medical Research Incorporated
2683 Palmer St, Ste B
Missoula
59808
United States of America

Sponsor information

Organisation

All American Pharmaceutical

Sponsor details

2376 Main Street
Billings
59105
United States of America
+1 406 245 5793
jeffg@allamericanpharmaceutical.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

All American Pharmaceutical

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in the Journal of Diabetes and Metabolic Disorders.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Wendy Lou Jones, MSc (WLJ_1998@yahoo.com) and Dr. Jeff Golini, PhD (drjeff@allamericanpharmaceutical.com)

Intention to publish date

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes